FDA Device Recalls in 2020
1,370 recalls found
December 2020
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Ensuring affected personnel are aware of the notice contents - Assisting the Zimmer Biomet sales representative with the quarantine of the affected products. Certificate of Acknowledgement complete and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC. Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed. Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Complete the enclosed faxback form and return it following the instructions on the form. File this UMDC for future reference. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
AC Powered hospital adjustable bed.
Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.
The firm sent a Medical Device Recall-User Manual letter dated May 4,2020 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify affected units. Units bearing the options numbers OL360011P or OL360017P and manufactured between January 26th, 2015 and January 24rd,2020 were packaged with a User Manual affected by this recall and subject to improvement with the attached addendum. A list of serial numbers traced as being in your facility is attached to this communication. The manufacturing date and serial number are located on the manufacturer label located at the head end of the device. Actions Needed: 1. Please carefully read the attached addendum and promptly disseminate its contents to all concerned personnel in your facility, including more importantly to all persons who are or may be called upon to use/operate the bed. 2. Locate the User Manual related to your FL36 bed and insert the addendum, for future reference, in the appropriate section of the instruction manual for the FL36 ook-snow, ook-snow MH or ook-cocoon beds. 3. If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. 4. If you have disposed of any of the affected beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. 5. Call at 1-844-409-4030 or at 1-418-247-3986, extension 4 to confirm that your facility received Umano Medical Inc.s addendum to the User Manual regarding the Zeroing Procedure and the Detection System applicable to the above-mentioned product(s) and that the Actions Needed have been taken and completed by your facility.
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Medtronic issued Urgent Medical Device Recall letter by letter delivered via Federal Express and/or certified mail beginning November 23, 2020. The letter states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed above. 2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3. If you have distributed the Covidien TA" Auto Suture" Vascular Stapler and Loading Unit with DST Series" Technology listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory We request that you contact Medtronic if you experienced a quality problem or adverse event. Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.
On December 20, 2018, Terrific Care, LLC. / Medex Supply Dist, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter (dated 12/19/18) of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/telephone/facsimile orders. On December 21, 2018, Terrific Care, LLC / Medex Supply Dist, Inc. re-issued an Amended Press Release identifying affected Catalog Numbers and lots. On December 26, 2018, recall notices were issued to customers via email. On or about January 29, 2019, Terrific Care, LLC. / Medex Supply Dist, Inc. re-issued Urgent Medical Device Recall and Response Forms to customers. Actions Required: 1) Immediately stop using and quarantine all CoaguChek XS Test Strips sold by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/phone orders/facsimile. 2) If you have product to return, please send an E-Mail to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between the hours of 9:00 am - 5:00 pm, Monday - Thursday. 3) Include your order ID, and insert - Recall- in the email subject line. 4) Complete and return the attached response form via email. 5) For reimbursement, contact Terrific Care by phone at 888-433-2300 or by email at RMA@medexsupply.com. - Patients, caretakers and health care providers should switch to new batches of CoaguCheck XS P Test Strips. New batches should be obtained by contacting Roche Diagnostics Corporation at 1-800-428-4674. -Patients who are using devices affected by the recall should contact their health care providers immediately to determine an alternative testing method while waiting for replacement strips that are not affected.
Zoll M Series External Defibrillator
Defibrillator may fail to charge or hold its charge above energies of 75 joules
Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
On 12/8/2020, Medtronic sent an "Urgent: Medical Device Recall" Notification via FedEx to affected consignees. In addition, to providing consignees information on the recall device, Medtronic ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected products within your inventory. The list of affected lots is included. 2. Contact Medtronic to return affected product and receive replacement(s). See instructions on next page. 3. Please complete and return the customer confirmation form, even if you do not have any affected product 4. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: - E-mail Medtronic at RS.MNSProdExperienceHelp@Medtronic.com or call 1-877-526-5432. Online at the FDA website1 (form available to fax or mail) or call FDA at 1-800-FDA-1088.
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue
The bone screw is shorter than the intended design specification.
The recalling firm, TriMed, issued a "URGENT MEDICAL DEVICE RECALL" letter via email on 8/24/2018 to the distributors and third-party distributor. A follow-up letter was issued 3/28/2019 requesting downstream customers be notified to the user level. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If the customer further distributed Hex Cortical Screws, 4.0mm that is the subject of this recall, to forward the letter and the return response card to those entities that utilized the impacted product. " If the customer utilized the Hex Cortical Screws, 4.0mm that is the subject of this recall, then the customer is to: o Review customer inventory (including any kits that you have prepared for surgical operation) to see if they have any of the impacted product. o If a customer does have impacted product within its inventory, remove the product from use. o Review customer records to see if the impacted product was implanted. If the customer has records that impacted product was implanted, the customer should apply medical judgment to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. o Return to TriMed a return response card by 11 April 2019. Please email the response to: quality@trimedortho.com. Please contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221 or Email: quality@trimedortho.com * Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays).
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Haag-Streit USA, Inc. notified accounts by Urgent Medical Device Correction letter via UPS on 11/20 and delivered 11/24, stating reason for recall, health risk, and action to take: Since the error only occurs when using the optional microscope accessory EIBOS 2, we recommend the following action: 1. Operate the focusing only as described in the instructions for use 668 600 part 5.4 when the fundus observation module EIBOS 2 is swiveled in (see following extract from the above-mentioned Instructions for Use). 5.4 During Surgery Surgery starts at the anterior segment of the eye. The operating microscope is focused on the cornea or the iris. The EIBOS 2 is folded upwards. " Fold the EIBOS 2 down to observe the posterior segment of the eye. " Focus the EIBOS 2 exclusively via its operating elements for focusing. Do not use the focusing of the operating microscope. " Use the foot switch to position the EIBOS 2 by means of the XV-coupling over the patient's eye. " Fold the EIBOS 2 up to observe the anterior segment of the eye 2. If the error occurs, press the focus button on the footswitch again. By pressing once more, the software error is corrected and the focusing works normally again. It is not possible for the error to occur twice in a row. Attention: After 10 seconds of focusing, during which the microscope moves in the direction of the patient's eye, the EIBOS 2 spring suspension to protect the eye is at the end position and the EIBOS 2 is pressed into the eye. 3. Perform a software update of the floor stand. You will receive the software version 3.4 through your local Haag-Streit USA representative who will fix the error. 4. Please send us the enclosed Acknowledgement Letter filled in as soon as the software update is complete. Transmission of the information Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward them a c
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. 5) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle to obtain a response form. For further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service, 1-866-829-9025, option 8 or, customerservice@icumed.com, (M-F, 8am-6pm CT) On 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
There is a potential software error during programming.
A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
Siemens Healthcare Diagnostics Urgent Field Safety Notice letter beginning November 23, 2020 via Fed Ex and outside the US the distribution is determined at the country level. Letter states reason for recall , health risk and action to take: For the product listed above, please perform the following steps: 1. Review and apply the preliminary precision performance characteristics of d8% CV at a GGT concentration of approximately 27 U/L 42 U/L provided. 2. Please review this letter with your Medical Director. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Customer Care Center or your local Siemens technical support representative. The precision section of the IFUs will be updated when the investigation is complete. The updated IFUs will be uploaded into Document Library where all registered users who opt in to receive alerts will be notified of the updated IFU.
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
The firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: Jenny.Jones@materialise.com.
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required on July 31, 2020, via BSC Sales Representatives. The Sales Representatives contacted accounts to determine whether or not the affected inventory had been used. If the product was not used at the site, the product was quarantined. Additionally, customer notification letters to the 32 consignees were sent via Federal Express Priority Overnight mail on July 31st, 2020. Letter states reason for recall, health risk and action to take: Your local Boston Scientific sales representative is available to support this removal. 1. Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific We recommend clinical re-evaluation of patients implanted with an uncovered stent from this lot to determine if stent removal is appropriate. 1. Immediately discontinue use of and segregate affected product. 2. Complete the enclosed Reply Verification Tracking Form. 3. Indicate on your Verification Form the quantity of units that you will be returning. 4. Email or fax the Reply Verification Tracking Form to the BSC Field Action Center as described Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Please email or fax your Reply Verification Tracking Form(s) immediately. Replacement devices will be issued for all product returning to Boston Scientific.
IceFORCE" 2.1 CX 90 Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
Customers will be sent a product advisory via overnight mail.
MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9277 MZ9278 MZ9279 MZ9280 MZ9281 MZ9283 MZ9287 MZ9288 MZ9289 MZ9290 MZ9292 MZ9293 MZ9294 MZ9300 MZ9301 MZ9302 MZ9313 MZ9323 MZ9324 MZ9325 MZ9326 MZ9327 MZ9329 MZT1003 MZT1004 MZX5302 MZXT5303 MZXT5304 M
BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
The firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the potential for croplets of fluid to separate from the sealed surface of the BD MaxZero following disconnection, potentially exposing the healthcare professional, the patient, and the surrounding areas. Customers are asked to do the following: Please Take the Following Actions: 1. Immediately review your inventory for the specified Catalogues (Ref) listed in Attachment 1. 2. Share this communication with all users of the product within your organization to ensure that they are also aware of the update to the disconnection technique of the BD MaxZero" and the associated extension sets. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
On 6/26/2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that a Steris service technician will contact customer facilities within 45 days to inspect their units and reperform the installation/start-up checklist. Users can continue to use their irrigator(s) prior to this inspection. Users were instructed to continue to visually inspect all instruments for visible debris prior to final high-level disinfection or sterilization, and reprocess if needed. In addition, users should continue to clean and maintain the unit before each cycle. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
On 10/07/2019, Product Correction and Product Safety Recall notices were emailed to customers. Customers were asked to replace the front leg assemblies as follows: a. Depress the push buttons on the original legs and remove them from the frame. b. Insert the improved replacement assemblies issued by NOVA into the unit and discard the original legs. In addition, customers were asked to do the following: 1. Check your inventory for affected walkers and fix. 2. Contact all customers who purchased affected walkers notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers the recalling firm can send the wheel assemblies directly to their residence. Have them inspect their walker immediately to identify if either of the front forks have unscrewed from the leg. If so, please instruct them to not use the walker until the leg assemblies can be replaced with the new parts. 3. Call the recalling firm to request the wheel assembly set to be sent to the required location. 4. Record the serial #'s of the product that have been corrected and email them to Customer Service (info@novajoy.com) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682 x8129. Email: info@novajoy.com
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
On December 20, 2019, the recalling firm distributed Urgent Medical Device Recall letters to affected customers. Customers were provided with instructions for determining whether the Lipase reagent cartons in their inventory were impacted. The next reagent lot is expected to be available by February 2020. Customers were asked to review the letter with their Medical Director, review their inventory for affected products, and assess their laboratory's replacement needs as applicable. A customer response form was included with the recall communication so that customers may confirm that they have received the notification as well as report the quantity of replacement product required.
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.
The firm initiated their market withdrawal by letter on 08/28/2018. The firm requested surgeons immediately cease implantation of the device and return any unused product.
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Product Notification letters dated 8/2/18 were sent to customers.
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
The printed expiration dates are incorrect.
An Urgent Medical Device Recall notification letter dated 3/6/2020 was distributed to customers. Actions to be Taken by the Customer 1.Examine inventory immediately to determine if you have affected product(s) and quarantine anyaffected product that remains unused. Immediately cease all distribution and use of this product. 2.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement andReceipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form forreturn instructions. Note: Unaffected products that are returned will not be credited. 3.Please complete the Acknowledgement and Receipt Form within 5 business days of receivingthis letter. Even if you do not have affected product(s) on hand, you must still complete theAcknowledgement and Receipt Form and return via fax (812.339.7316) or email(FieldActionsNA@CookMedical.com). 4.This notice must be shared with appropriate personnel, including down to the user level, withinyour organization or with any organization where the potentially affected devices have beentransferred. 5.Immediately report adverse events to Cook Medical Customer Relations by phone at800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (EasternTime), or by email to: CustomerRelationsNA@CookMedical.com.
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Due to complaints received associated with cracked/split test tube caps.
On 11/09/2020, international distributors were initially contacted and provided with a notification for distributors letter. On 11/16/2020 domestic customers were contacted via telephone and then a formal notification was delivered. The Recalling Firm was informing its customers to the potential of defect associated with the (flip-top) caps for some test tubes where the cap my split resulting in leaking of biohazardous fluids as users are instructed to shake the tube for proper mixing. Customers are instructed to immediately examine their inventory and quarantine affected product. If customers have further distributed the affected product, they are asked to identify the users within their facility to notify them at once of this product recall. Customers are also asked to complete and return the response form as soon as possible. For any questions, customer can email or call the Recalling Firm as jhanka@Helena.com or 1-800-231-5663 extension 1177.
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasoni
This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
On November 3, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to do the following: Interim Recommendations until your EKOS CU4.0 console has been exchanged: In order to avoid the channel errors described in this notice: 1- Store the Control Unit at room temperature, in a well-ventilated area. 2- The console should be plugged in and powered on for 30 minutes prior to making connections and starting therapy to allow the Control Unit to warm up to operating temperature (+15C to +40C) Customers were also asked to complete and return the verification form to their local Boston Scientific office. The recalling firm will provide affected accounts with an updated CU 4.0 unit with a newly designed RF board.
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
The recalling firm issued a Dear Healthcare Professional letter dated 12/6/2018 via FedEx explaining the issue and requesting the consignee examine their inventory and quarantine the percutaneous pin adapter for return to the firm. Only the percutaneous pin adapter was to be returned and not the remaining items in the assembly.
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
Starting on 01/22/20, Important Medical Device Correction notices were hand delivered by the recalling firm's sales representatives. Physicians were informed that the recalling firm developed a software patch for programmers which restores wireless RF communication capability in affected devices. Device explant is not required for the update. The recalling firm will assist in updating programmer software and restoring wireless RF communication for affected devices. Correction notices recommend working with firm representatives to help correct affected devices during the patient's next regularly scheduled visit. Physicians were asked to complete and return the Acknowledgement Forms and to retain the correction notice. Customers with additional questions were encouraged to call Technical Support at 1-800-722-3774.
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
On May 3, 2019 a customer letter (in an envelope marked URGENT) was Federal Expressed overnight-signature required to the 16 customers who received the 26 devices. The specific actions to be taken by the customer/user that were shipped the product affected by the recall are requested to do the following: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete an enclosed Acknowledgement Form, even if they have no remaining devices in their inventory, and return the completed Acknowledgment Form via mail: Mail: DBM Recall 664 Cruiser Lane Belgrade, MT 59714 Email: mdolan@xtantmedical.com Fax: 1-406-388-3380 3. Contact via email: mdolan@xtantmedical.com, or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices which will be provided at no cost. 4. Package the affected products to be returned. The firm will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container to: ATTN: OSTEOSELECT DBM RECALL (RMA Number) 732 Cruiser Lane Belgrade, MT 59714 For questions, please contact the Director of RA/QA at 1-406-388-0480 ext. 1128, from 8 a.m. to 5 p.m. (Mountain Time).
SAROS Oxygen System Model 3000
There is an electronics control issue that causes the unit to not power on with battery power only.
The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.
CardioLab/ComboLab Recording Systems
Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
GE Healthcare notified customers of the recall on about 09/16/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that certain CLab II Plus Amplifiers used with CardioLab/ComboLab systems have failed the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient. Instructions included that customers could continue to use the system by following the below instructions: 1. Test all equipment used in conjunction with CardioLab/ComboLab per manufacturer instructions on electrical safety to ensure that all equipment is in good operating condition and performs per manufacturer specifications. Note: Due to the potential safety risks of other devices used in conjunction with CLab II Plus Amplifiers in Electrophysiology Procedures, all equipment that can electrically contact the patient during a procedure should be checked against each devices safety conformances in manufacturer specifications. 2. If you suspect another connected device is or may be malfunctioning, discontinue use of the CLab II Plus Amplifier until all nonconforming equipment is corrected. If nonconforming equipment is used in conjunction with the CLab II Plus Amplifier, the CLab II Plus Amplifier will not provide necessary mitigation to prevent patient shock. Customers were also informed that GE Healthcare will correct all affected products and a GE Healthcare representative will contact customers to arrange for the correction. They were asked to complete and return the "MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT" form.
DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" dated 12/17/2018 to its consignees by letter on 12/17/2018. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Check your inventory for the specific product and lot number listed. 2) If you have affected inventory, complete the Notice of Return Form and return it to recalls@deroyal.com or fax to: 865-362-3716 not later than January 29, 2019. 3) PLEASE COMPLETE THIS FORM AND RETURN IT EVEN IF YOU NO LONGER HAVE ANY INVENTORY.PL EASE CONTACT CUSTOMER SERVICE REPRESENTATIVE AT 865-362-4203 OR EMAIL AT JMARSH@DEROYAL.COM FOR RETURN INFORMATION. 4) Once we have received your Notice of Return Form, you will be given credit or replacements as you have indicated on the form. 5) If you have further distributed these products, it is required that your customers be notified of this recall. You may either do this directly and notify us that you have done so, or you may provide us with your customer listing and we will contact them. If you have questions or need assistance with the recall, please contact your DeRoyal Representative, customer service at 888.938.7828, or email us at recalls@deroyal.com.
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
On May 2, 2019, the firm sent Guidance for SenTec Distributors to their distributors advising them of the issue, requesting them to check their stock and notify their end users via a voluntarily initiated field correction action associated with Membrane Changers and their Inserts which was enclosed with the "recall" letters. The distributors were to report back to SenTec via email.
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees.
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
On June 3, 2019, SunTech Medical sent an Urgent Medical Device Customer Notification to their one consignees advising them of the issue and requesting that they completed the enclosed Recall Acknowledgement Form. This letter further request this consignee to conduct a sub-recall by using the provided Customer Template Letter and Recall Acknowledgement Template.
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.
The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative.
VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Customers have reported that some VITEK 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 07/12/2017. The direct consignees (subsidiaries and distributors) have until 08/12/2017 to notify their respective impacted users. The directions to the user are as follows: Please implement the following actions at this time: " Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. " Refrain from performing the VITEK 2 Systems Software 8.01 update. o A solution has been identified, and your local bioMrieux representative will contact you with further instruction in the coming weeks. " If you have updated VITEK 2 Systems Software to version 8.01 within the last seven (7) days, please contact your local bioMrieux representative. " Please store this letter with your bioMrieux instrument documentation. " Complete the Acknowledgement Form and return it to your local bioMrieux representative."
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
The firm, Accuray, disseminated their "Urgent Field Safety Notices" dated 08/31/2018 by email and letter to its customers. The letter described the product, problem and actions to be taken. The letter requested the customers cease use and quarantine the product for recovery and replacement by an Accuray Representative and complete and return the Acknowledgement Form via email at: astsauver@accuray.com or mail to: Accuray Incorporated, one Erdman place, Madison, WI 53719. If you have any questions, contact Vice President, Regulatory Affairs at 608-824-2800 or email: dbiank@accuray.com or the Regulatory Affairs Specialist at 408-716-4660 or jysingh@accuray.com.
PENTARAY NAV High-Density Mapping Catheter.
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Recall Notification letter, dated 04/14/2016, and Acknowledgement Form was sent to customers via express mail on 05/17/2017. Instructions included to read and follow Labeling Correction Notice carefully, provide the notice to anyone in the facility that should be aware, sign and return the Acknowledgement Form, and to maintain awareness of the correction.
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Intersurgical Inc. issued Urgent Medical Device Recall notices to customers dated August 5, 2019. Customers were advised to take the following actions: 1. Immediately discontinue use and quarantine any stock with the product/lot number described in the recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. a. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: i. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. ii. The subject line should contain your Company name and RGA number. 1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. b. Intersurgical will credit your account when the product is received. 4. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. a. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. b. The subject line should contain your Company name and Intersurgical Recall
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
The firm, Ohio Medical, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to customer.service@ohiomedical.com for additional instructions to replace the wiring harness; and complete the attached Customer Acknowledgement Form and return it to our Quality Assurance Department at 847/855-6304 (fax), email to: CEV3_FCA@ohiomedical.com, or mail in the envelope provided to: Ohio Medical LLC, ATTN: Quality Assurance Department, 1111 Lakeside Drive, Gurnee, IL 60031. Please direct questions to Sr. Director, QA/RA at 847-855-6326 or email: barbara-ann.conway-myers@ohiomedical.com.
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Incorrect product and/or label. Sizing is labeled incorrectly.
An URGENT MEDICAL DEVICE RECALL was sent on December 05, 2017 Product Field Action #: 1658081 Description: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7 Item No.: 180612; Lot Number: 26080317-01180617; and Lot Number: 26150217-01 Dear Customer, Stryker has initiated an urgent, voluntary, lot-specific recall for the MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLA TE-RM/LL-SZ 7 referenced above. The intent of this letter is to inform you of the product recall that was initiated on December 01, 2017 by Stryker, and to list known hazards potentially associated with the use of the above referenced products and list the risk mitigation factors. Stryker has discovered that the packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. Two reports were received with the product/label discrepancy. In one report, the labeling of the implant box outer label stated Size 2 RM/LL, and the labeling of the implant sticker (Patient label) located inside the outer box stated Size 7 RM/LL. The correct implant Size 2RM/LL was inside the box. The patient label was incorrect in this report. The second report described that a size 2 implant was in a box labeled as a size 7 implant. Potential Hazards Technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. Additional communication will be forwarded upon completion of the internal investigation on this issue. Risk Mitigation The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and would not likely be implanted as the discrepancy would be obvious. Actions Needed 1. Please inform users of this Urgent Product Recall and forward this notice to all individuals who need to be aware within your organization 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculatin
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
The firm notified their consignees by email on November 3, 2017. "Instructions to customers what to do with the recalled product. For instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached Field Safety Notice / Product Notification letter CAPA-20171011-001985: 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam. 2. Do not use the Virtual Isocenter function if a verification of the patient position in the treatment isocenter is not feasible. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Clinical User Guide ExacTrac Vero: Brainlab highly recommends performing an X-ray verification after each change to the couch/Robotics Position." For further questions, please call 1 (800) 784-7700.
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Product was manufactured utilizing an expired inner body.
Cordis notified customers on about 10/04/2019, via Urgent MEDICAL DEVICE RECALL letter delivered by sales representatives. Customers were informed that the Cordis MAXI LD" PTA Dilatation Catheter was manufactured utilizing an expired inner body. For an expired inner body, a degradation of material may contribute to a collapse of the guidewire lumen resulting in a resistance during insertion or backloading of the guidewire into the lumen. Instructions included to read the recall letter, immediately check inventory to conform if the affected product is in your possession, identify and set aside any units from the affected lot, complete and return the provided Acknowledgement Form directly to Cordis via fax (614-495-5571) or email to GMB-FieldCorrectiveAction@cardinalhealth.com. Customers were also instructed to arrange for return of affected product, provide the recall letter to personnel at your facility who need to be made aware and any other facility that may have been sent the affected units.
2000 Vascular with 30 Degree option
Potential for bed to drop suddenly at the head while a patient is laying on it.
Heritage Medical Products, Inc. notified customers on about 09/02/2016 via "Advisory Notice." Customers were informed that Heritage Medical has designed a reinforcement kit as a correction, which will be supplied to customers. Customers were instructed to contact Heritage Medical, provide the serial number of their bed to ensure it is affected, and Heritage Medical will provide a free kit that will reinforce the area on the affected devices that has experienced failures. The contact information is a follows: Heritage Medical Products, Inc., ATTN.: Trunnion Reinforcement Kit, 10380 CR 6310, West Plains, MO 65775, (888) 256-8748.