FDA Device Recalls in 2020
0 recalls found
January 2020
Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539
Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).
On 7/19/2018, the firm sent an Urgent Medical Device Recall Notice to distribution chain/consignees via e-mail informing them that, in some cases, the S4 Peripheral IVL Catheter is not performing as intended. We have seen instances of leaks in the balloon which prevent the balloon from staying inflated at 4 atm for the full course of lithotripsy application. There have been no reports of adverse clinical events related to this issue. This issue does not impact patients who were previously treated with the S4 device. Customers were instructed to discontinue use of all S4 IVL products listed in the recall and place it into quarantine until a Shockwave representative was able to arrange for the S4 IVL product to be returned to Shockwave Medical. The Shockwave representative retrieving the product from the customer is to complete the Acknowledgement and Receipt Form. Recall Contact Nora Hadding Vice President, Quality and Regulatory Affairs Email: nhadding@shockwavemedical.com Phone: 510-279-4262 Monday through Friday, 8:00 AM to 4:30 PM Pacific time.
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
The affected device was retrieved from the only customer on 9/4/19. An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
The firm initiated their field notification by email on 09/25/2017. The firm provided details on the issues and requested the user to take the following actions: "If you notice any of the anomalies as described above before being contacted by a Leica Microsystems representative, please contact your Leica representative for relevant repair of your PROVEO 8. You can continue to use the system pending the intervention of the appropriate Leica Microsystems representative. However, please ensure that a functional check is performed and the system is properly balanced prior to surgery as required by and described in chapters 17.1 Checklist before operation and 7.7.1 Balancing the parallelogram of the user manual. During surgery, ensure that no functional switches are activated at the same time as a user profile or mode is changed. During the start-up of the system, ensure that no functional switches are activated until the system boots up."
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and product return sections of the attached Business Reply Form (BRF)). A local Acclarent sales representative will contact you to retrieve the recalled products. Use the enclosed prepaid shipping label and attach a copy of the completed BRF with your product return. 3. Complete the BRF within three (3) business days of receipt even if you no longer have inventory of the identified products. Upon receipt of the completed BRF and your product return, your account will be credited. Incomplete BRFs cannot be processed. 4. Ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 5. Maintain a copy of this communication where the inventory of the lots identified in this letter is located until all products are returned. 6. If you have product complaints or adverse events to report regarding the use of Acclarent products, please inform Acclarent by calling (650) 687-5888 7. For questions related to this issue and product recall, please contact your Acclarent sales representative or call (650) 687-5888
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.
"On May 7, 2018, the firm sent Urgent Medical Device Correction letters to affected Retailers, Suppliers, and Patients. Patients were instructed to check their test strip supply lot numbers against the recalled lots. Any test strips from the affected lots must be discarded. To get replacement test strips, patients should use one of the following options: o For fastest replacement of your product, please submit your request at https://notices.accu-chek.com o Email Accu-Chek Customer Care at accu-chek.care@roche.com and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o For questions regarding this recall, contact Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. Suppliers were instructed to discontinue distribution and dispose of any remaining stock of the affected lots immediately. Suppliers were also asked to forward recall notifications to their customers, including both supplier- and consumer-level customers. Suppliers were asked to complete a faxback form indicating the total number of vials disposed of by the supplier and supplier customers. If you are a supplier and have questions about the information in this notification, please contact your Roche Account Manager. Retailers were instructed to discontinue sale or distribution and dispose of remaining affected lots in stock. Retailers were also asked to provide recall notification to their consumer customers. Retailers may note the quantity disposed and contact their Suppliers to arrange for credit. For questions please contact your wholesaler or the Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time. "
Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
Reckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns.
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipu
Potential hardware issue which may cause thermal effects and possible damage to system parts.
On June 22, 2018, Siemens Healthineers issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. In the event the problem occurs, the system can be operated normally, however, in the case of a leakage current, X-ray will not be possible. This may result in a situation where it is necessary to cancel or restart clinical treatment or to continue treatment on an alternative system. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the error by updating all affected generators with a RCD (Residual Current Device) to detect leakage currents via Update Instruction AX060/16/S. Additionally, Siemens recommends installing a RCD (Residual Current Device) in the electrical system of the hospital as an appropriate backup system and general electrical protection. You may continue to use the Artis Q and Artis Pheno systems while awaiting implementation of the corrective action. Siemens Healthineers will contact customers to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
On January 26, 2018 RaySearch Laboratories AB sent Field Safety Notice, Medical Device Correction #25955 to each customer via e-mail. Customers were advised of the following: be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended; do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam; please educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification via email, fax or by calling local support. Customers with questions were instructed to contact David Hedfors via e-mail at david.hedfors@raysearchlabs.com
26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550
There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.
Urgent Medical Device Correction - Recall Notification letters were distributed on 6/4/18. The letters instruct customers to perform the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the above mentioned products in your organization and other concerned persons are informed about this medical device correction - recall notification. If you are a distributor, please forward this recall notification to your customers. 2. Perform a visual inspection of valve orientation prior to installation onto APEX Compounding System in accordance with the Visual Inspection Instructions contained in Attachment 1. 3. If any misaligned valves are identified, do not use the transfer set. Please contact Customer Support at 1-800-227-2862 for product return and replacement. 4. Utilizing the attached "Medical Device Correction - Recall Notification Acknowledgement" form, please acknowledge that you have received and reviewed this information. 5. Return the completed "Medical Device Correction - Recall Notification Acknowledgement" form to B. Braun Medical Inc Quality Assurance department by faxing or e-mailing the form within two (2) weeks of receipt of this notice. It is important this form is returned to B. Braun Medical Inc can meet regulatory requirements of the United States Food and Drug Administration.
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.
On July 2, 2018, the firm notified customers of the recall via an emailed Urgent Medical Device Removal letter. Customers were informed that the company had received three complaints of electrical shock when using the device, and that the device and its accessories may not have been manufactured according to current good manufacturing practices. ACTIONS TO BE TAKEN BY THE CUSTOMER 1. Dispose of the iTOVi Scanner and its power adapter and charger in the trash. 2. Fill out and return to us the enclosed Attachment A: Urgent Removal Response Letter. The bottom of the form identifies three different methods of returning this form to iTOVi. 3. Forward this letter to any users to whom you may have distributed the device. 4. If you or others have encountered any illnesses or injuries during or after use of any iTOVi Tracker/ Scanner products, iTOVi recommends that you arrange for yourself and other product users to seek medical attention. TYPE OF ACTION BY THE COMPANY: As of June 15, 2018, all iTOVi Tracker/ Scanner software applications (apps) will be deactivated via the following steps: 1. Using the server-based software that handles iTOVi account logins, iTOVi will disable the iTOVi computer software application that runs on iOS and Android operating systems for all iTOVi devices. 2. iTOVi will issue an update to the iTOVi software application which displays a message saying that the iTOVi Scanner device is no longer usable and should be disposed of in the trash. iTOVi is in the process of creating a more reliable, innovative iTOVi Scanner, and will be sending out a new device to replace older models.
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
On February 23, 2018, Medcomp distributed Product Recall and Distribution notices to international distributors via email and to U.S. facilities via courier service on February 26, 2018. Medcomp is requesting the return of all un-used affected product. Customers should immediately examine inventory and quarantine product subject to recall. If for any reason the product was further distributed, please identify the recipients and notify them at once of this product recall. Your notification may be enhanced by including a copy of this recall notification letter. Contact your customer service representative for a Returned Goods Authorization number if necessary by calling (215) 256-4201. Complete and return the Distribution Notice via fax (215-256-9191) or email (complaints@medcompnet.com.
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
The firm disseminated an urgent medical device correction notice on 12/12/2019. The notice explained the issue and provided the following actions be taken: 1. Baxter will be tightening its internal specifications for the D mold to produce Luers that target the mid to upper range of the ISO specification (target date December 2019). Additional actions, as needed, will be determined through investigation. 2. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 3. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please distribute this notification to customers and check the associated box on the reply form. For general questions regarding this communication, contact Baxter Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
The firm first issued recall letters on 11/28/2018 via FedEx for Part number 6534-09PT and then on 12/28/2018, issued recall letters for Part number 6530-09PT via FedEx. On 2/14/2019, the firm issued another letter to their consignees that added a risk statement regarding the recall of both part numbers (6534-09PT and 6530-09PT).
HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Eurotrol distributors and initial consignees contacted via e-mail with the recall notification letter on 10/16/18. The recall notification letter sent via overnight mail in case e-mail is not deliverable. The recall notification letter instructs distributors how to perform the subrecall towards end-users and inform Eurotrol about the performed subrecall actions Primary instruction will be to stop using the product (discard according local regulation on medical waste) and contact Eurotrol for replacement material. Questions, contact (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time): Name: Eurotrol Inc. Address 850 N Black Branch Rd. Zipcode & city: Elizabethtown, KY 42701 USA Phone: T +1 502 501 1180 E-mail: officeusa@eurotrol.com.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
Vygon sent an Urgent Medical Device Recall letter dated October 3, 2017. Customers requested to check stock and quarantine affected devices and to complete Recall Acknowledgement and Inventory Return Form. Customers instructed to fax or email the form to Vygon including customer contact info. Vygon will contact the customer and issue a Return Merchandise Authorization Number. Distributors instructed to communicate recall to customers who received affected product and provide them copy of the recall notification. Returned products were received in Lansdale, PA warehouse location and placed into quarantine. For further questions, please call Customer Service at (800) 473-5414.
GIZA Vertebral Body Replacement
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
A correction letter to the users was sent on March 28, 2017 Stating the following: Eden Spine Europe has become aware of extremely rare incidents of disassembly of Giza devices, which is distributed by Stryker Spine in the USA. These incidents have occurred in limited situations when a surgeon has needed to unscrew the device in order to readjust the distraction. To mitigate this risk, a more precise description of the unlocking procedure in the Giza Surgical Technique was added to prevent surgeons from fully unscrewing the locking screw. POTENTIAL HAZARD In the unlikely event the Giza device was to disassemble, the potential hazard is that the surgeon may decide either to reassemble the device or change the implant to a new device. This could potentially lead to a short surgical time delay of 2 to 10 minutes. RISK MITIGATIONS Eden Spine Europe and Stryker have added the following information in the Giza Surgical Technique to mitigate the risk of disassembly of the device: Note: If adjustment is needed, the implant locking mechanism must be unscrewed 3.5 to 4 rotations from the tightened position, to free the superior cylinder from the inferior one. No more than 4 counterclockwise rotations should be applied to the locking screw, as doing so could potentially lead to disassembly of the implant's locking mechanism. The GIZATM Vertebral Body Replacement surgical technique is available on Stryke Spine's website. ACKNOWLEDGEMENT OF THIS NOTICE Please acknowledge within 5 days of receipt of this notice: - Fill out and send the following online for: https://fr.surveymonkey.com/r/5XYT3ZQ - Or Send an Email to the following address: Customer.service@edenspine.com stating that this notice was received. For any questions you may contact: Christophe Zuanon, Regulatory Affairs & Quality Assurance Manager c.zuanon@edenspine.com Manager, c.zuanon@edenspine.com
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
May result in elevated platelet backgrounds during routine startup/background checks.
The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.
ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 29, 2016 to be delivered to customers on August 1, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 28, 2016. These emphasize that the prostate specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.g., the 2013 American Urological Association (AUA) Guidelines or the 2015 European Association of Urology (EAU)). These guidelines define biochemical recurrence of prostate cancer as a detectable or rising PSA value post-radical prostatectomy that is > or = 0.2 ng/mL (ug/L) with a second confirmatory level of > or = 0.2 ng/mL (ug/L). The communications also provide functional sensitivity from a recent study to give an expectation of precision at the low end of the assay.