FDA Device Recalls in 2018
773 recalls found
November 2018
Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Product malfunction: Needle does not retract.
Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Non-sterile product was packaged inside a case that was labeled as sterile.
DeRoyal sent an Urgent Recall Notice letter dated April 23, 2018 to affected customers. The letter identified the affected products, problems and actions to be taken. The recall notices requested destruction of the product at the consignee level. Distributors were asked to notify their consignees or to provide the list to DeRoyal for notification. For questions contact your DeRoyal Representative, customer service at 888-938-7828 or by email at recalls@deroyal.com
Medtronic CareLink 2090 Programmer
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
The firm began disseminating the Field Corrective Action notices by hand delivery on 10/02/2018 and followed with the posting of Medtronic Security Bulletin and the Urgent Medical Device Correction customer letter online on 10/11/2018. The notice explained vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download and beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method.
Hitachi Oasis MRI System - C-Spine Coil
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Hitachi sent an Urgent : Device Correction Notice dated January 3, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to visit each site and replace the cable balun and also confirm receipt of the notification letter. The firm will quarantine returned baluns in their warehouse until they are reworked. For further questions regarding this recall please call (330) 425-1313 ext. 3720.
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
Consignees were sent on 12/7/2015 a GE Healthcare "Urgent Medical Device Correction" GEHC Ref#60888 letter dated December 7, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Scanners. Because 3.0T 6 Channel Flex Coils are used with the MR750, MR750W, and 3.0T HDxT (including HD23), these devices have been added to the letter. There are no other changes to the letter. UPDATE 5/27/16: Consignees were sent a revised letter on May 19, 2016. The letter topic stated "De-rating of 3.0T 6 Channel Flex Coil when used on Discovery MR750 running DV24, DV25, or DV25.1 Application Software" . The letter described the Safety Issue, Safety Instruction, Affected Product details, Product Correction and Contact Information (same as previous letter).
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
On February 13, 2017, the firm emailed its distributors to notify them that their Rev. A devices would be replaced with Rev. B devices, and asked the distributors to mail back the Rev. A devices.
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. Customers were instructed to do the following: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to technical.services@randox.com within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.
Hospira sent an Urgent Medical Device Correction letter dated July 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter provided instructions for step-by-step process to mitigate the issue. Customers with questions were instructed to contact Hospira Global Complaint Management at 1-800-441-4100 or Hospira Technical Service Center at 1-800-241-4002, option 4.
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
The firm, Ziemer Ophthalmology, initiated their field correction by telephone on 01/21/2018 and followed with a letter on 01/28/2018. The letter described the product, problem and actions taken. The letter stated: "...we will be releasing new software which contains an added safety feature which will prevent unintended shift of the planned ARC Incisions and/or alert you in case of unforeseen eye movement between configuration and execution of the ARC incisions. We will be contacting your practice the week of March 12th to set up a time to install this new software and provide in-depth training. Prior to the installation of the new software, you may continue to use the Z8 for cataract surgery; however, we would advise that you not perform both arcuate and clear corneal incisions on the same patient until the new software is installed. If you have any questions, do not hesitate to contact Director of Operations at 618-462-9301 for any further information you require.
October 2018
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
The firm initiated the recall on 02/14/2018 by letter and followed up with another letter on 03/12/2018 to clarify the labeling issue. The letter to the distributor stated: "1. Immediately discontinue distribution and quarantine any products with the catalog and lot number listed above. 2. Inspect affected products within your control to identify if the box label correctly identifies the products inside the box. Products with an incorrect label on the box should be returned to Teleflex Medical so that they are not distributed to health care providers in error. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. Customers may return mislabeled products if they choose to do so. Note the attached Customer Letter template was updated since this letter was first sent to you. 4. If any of your customers wish to return affected products, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-246-6990." The customer letter requested discontinuation of use and quarantining of products and return of affected stock.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
Arthrex notified customers on or about 08/27/2018 via recall letter entitled "URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATION." The recall letter instructed customers to immediately discontinue use, sale and distribution of the affected product and contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com as soon as possible to arrange for return of affected product.
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.
CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
SmartSite Add-On Bag Access Device, Model No. 10013365
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy at (888) 812-3266 or by email at customerfeedback@carefusion.com. Customers are instructed to complete and return the enclosed mandatory customer response card.
Alaris PC Unit, Model 8015
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to call (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions are instructed to call (888) 812-3229 or email dl-us-inf-techsupport@carefusion.com. For further questions, please call (858) 617-5925.
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
The firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229.
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
The firm, Qualigen, sent an "URGENT: PRODUCT RECALL" letter dated 7/5/2017 to its customers by email or fax on 07/07/2017. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the products immediately; discard any product remaining in your inventory; and complete, sign and return the attached CONFORMATION OF NOTIFICATION form by email to: babugan@qualigeninc.com or nsomera@qualigenic.com or fax to: 760-918-9127 by 7/15/2017. Please contact System Support at 877-709-2169, Option #2 if you need further assistance.
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
On 05/20/2018 the firm sent an Urgent Medical Device Correction letter to customers via United States Postal Service return receipt mail informing them that when a user used the respiratory gating with Steady Mode ON in Spin Echo sequence scan, the SAR value displayed on console was lower than the actual SAR value because there was a wrong estimating the RF pulses in the software. The SAR may exceed the upper limit, when a user scans a patient near the upper limit of the first level controlled operating mode in case of using the respiratory gating with Steady Mode ON in Spin Echo sequence scan. That may cause a burn of a patient. Applicable System/Model: -MEXL-1504/MEXL-1510: Vantage Titan -MEXL-1520: Vantage Elan Corrective Action: Modified system software to correct this issue will be installed on your system. When the software becomes available, your Canon service representative will contact your for an appointment to schedule the installation. Request to Customers: Until the modification is completed on your system, do not use Spin Echo sequences when using respiratory gating with Steady Mode ON. If you wish to use respiratory gating with Steady Mode ON, use Fast Spin Echo sequences. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. Customers are instructed to please complete the attached form and fax it to the toll-free number shown at the top of the form. This form can also be sent via email to RAffairs@us.medical.canon. If you have any questions, please feel free to contact Regulatory Affairs at (800) 421-1968 or your local service representative at (800) 521-1968.
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in pr
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
The firm initiated their recall by email on February 1, 2018. The letter stated the following: "Required Actions: 1. Please inspect your inventory and locate any unused devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the batch numbers and quantities of each batch that you are returning in the appropriate boxes below. 4. Complete the remainders of the form sign and send to FieldActions@smith-nephew.com or fax to 901-566- 7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com." For further questions, please call (901) 396-2121.
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
The product was mislabeled with the incorrect label.
Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to bd4964@stericycle.com; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even if you do not have any affected lot in your inventory. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-888-628-0732 between 8AM and 5 PM ET Monday through Friday.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.
CDRH approves the CAP subject to the following conditions for Claymount Assemblies BV: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. All forward production of Harmony devices must be properly tested, labeled, and reported when imported into the United States. For further questions please call (630) 271-9729.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.
MEDICAL DEVICE RECALL letters dated March 15, 2014 were sent to all direct accounts. The letters includes instructions to: 1) complete and return the Acknowledgement and Receipt Form accompanying the letter; 2) replace the Harmony2 Bucky(s) with new Harmony3 Bucky(s) that the direct account will be receiving in the near future; 3) if the direct account is a distributor and/or installer and it elects to have their customer(s) perform the replacement, the customer(s) should be provided with a copy of the letter, the replacement Harmony3 Bucky(s), and the replacement notification card, or the direct account can provide the names and addresses of their customers in which case Claymount will contact the customers directly; and, 4) once each unit is replaced, the replacement completion notification card should be mailed or faxed to the Claymount USA office and the Harmony2 Bucky(s) should be returned to "Claymount Americas Corp., ATTN: Alice Packard, 2545 Curtiss St., Downers Grove, IL 60515-4059" or faxed to 630-271-9995. For questions customers were instructed to call the following numbers: USA (630) 271-9729 EUR +31 315 659 150
PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email to complaints@wmt.com or fax to 901-867-7401. Customers with questions should call 901-451-6144.
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to corporatequality.postmarket@zimmerbiomet.com.
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Recall notification letters were sent to affected customers on 7/6/2017. The recall notice included a response form and instructed consignee to return any unused devices..
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced t
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623.
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; 300" Ext Set w/Remv
ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
ICU Medical, Inc. sent an Urgent Medical Device Recall Notification dated August 31, 2017. Customers will be instructed to quarantine any devices and return to ICU. Recipients will be instructed to continue the recall through to the end user of the device. Please call Customer Service, Monday through Friday between the hours of 7 am through 4:30pm CST @ 877-946-7747 and select option 9, or e-mail the following address: Productreturns@icumed.com
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Product may overheat, melt, and burn patient.
On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Action To Be Taken: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email to (fieldactionsna@cookmedical.com). 4. Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. 5. Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via customerrelationsna@cookmedical.com. This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: vigiliance@iba-group.com
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Customers were notified via letter on approximately 02/21/2018. Letters were sent via certified mail or email. Instructions included to discontinue use of the system (according to the cardiac imaging protocols listed in the letter), ensure the customer advisory notice is placed in the Biograph Horizon Operator's Manual, ensure the recall information is disseminated to all operators of the system, coordinate the installation of the updated Universal Physiological Measurement Module with Siemens Healthineers, and if the equipment has been sold to forward the letter to the new owner.
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.
There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
The firm, Ad-Tech Medical Instrument Corporation, sent a "MEDICAL DEVICE RECALL" letter on approximately 12/20/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine inventory and quarantine any affected product on hand; notify customers of the recall if affected product was further distributed; complete and return the Acknowledgement and Receipt Form via Fax to: 262-634-5668, Attention Customer Support; Mail to: AD-TECH MEDICAL INSTRUMENT CORPORATION, 1901 WILLIAM STREET, RACINE, WI 53404 or Email to: customersupport@adtechmedical.com, and contact an Ad-Tech Customer Support Specialist for a Return Material Authorization (RMA) number. If you have any further questions, contact Regulatory Team Representative and CAPA/Complaints Manager, Monday through Friday, 7:00 AM to 5:00 PM, Central Time via FAX: 262-634-5668, Toll Free: 1-800-776-1555 or Email: customersupport@adtechmedical.com.
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
The Philips Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to QualityAssurance@owens-minor.com that your customers were notified.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Customers were notified via letter on about 12/14/2017. Instructions included to immediately discontinue use of the ARCHITECH DHEA-S assay with samples form infants up to 60 days old, to immediately discontinue use of the ARCHITECH DHEA-S reagent insert Expected Values representative data for children up to 10 years old, to review the letter with the Medial Director and follow the laboratory protocol regarding the need for reviewing previously reported patient results, to forward the Product Correction letter to customers if the product was further distributed, and to complete and return the Customer Reply Form. Questions from U.S. customers can be directed to Customer Service at 1-877-4ABBOTT (available 24 hours per day, 7 days a week) and customers outside the U.S. should contact their local area Customer Service.
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG,
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
The firm issued the Medical Device Correction Notice on 09/04/2018 by letter. The letter explained the issue and provided the following safety instructions: If a prolonged network overload occurs and CARESCAPE Monitor Bx50 on the network does not resume normal functionality in approximately 90 seconds, take the following actions: 1. Temporarily switch the monitor from central monitoring to local-only (bedside) monitoring: - Disconnect the LAN cables from IX/MC ports on backside of the monitor. The monitor will now be in local-only mode. - Keep the patient under close observation and continuous surveillance at the local (bedside) monitor. 2. Contact your IT department or other appropriate personnel in your facility responsible for the Patient Monitoring Network, and provide them with the further instructions on network configuration. 3. After the network issue has been resolved, switch the monitor back into central monitoring by re-connecting the LAN cables to IX/MC ports. 4. Verify correct monitoring state and alarm function. If a transient network overload occurs in which the CARESCAPE Monitor Bx50 on the network restarts within approximately 90 seconds (i.e., all functionality resumes and the monitor reconnects to the network automatically), proceed with instruction step #2 above to check network functionality.
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
EOS Imaging sent Field Safety Notice letter and Removal Instructions May 30, 2017. Customers are to immediately discontinue use of the grab handles and remove them from all affected units from inventory and return to a EOS Imaging. For further questions please call (678) 564-5400.
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
On November 22, 2017, the recalling firm will send consignees customer letters with replacement product, requesting nonconforming product to be returned to Implant Direct with return labels and packaging. The recalling firm will then initiate calls 24 hours after the communication is sent to the clinician; initiate second calls 72 hours after the communication is sent; and initiate third calls 5 working days after the communication is sent. For further questions, please call (818) 444-3300.
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
On June 30, 2017 an urgent recall letter was mailed to customers with the following instructions: Customers who have affected devices should immediately take the following steps: (1) Alert all users of 731 Ventilator models to this problem. (2) Direct users to always verify device parameters after selecting the device Confirm button. (3) Contact ZOLL's Technical Service Department or your local ZOLL Service Provider to schedule a software update for affected devices Our 24/7 technical support numbers 1(800) 348-9011 or +l (978) 421- 9460 are available to assist users with any aspect of this notice.
Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.
HighPuragar was mislabeled and inadvertently sold as Noble Agar.
On October 3, 2017 an URGENT MEDICAL DEVICE PRODUCT RECA:LL letter was mailed to customers informing them of the recall and requesting that their inventory be checked for product, which should be quarantined and then thrown away. Also, to share notification of recall to any other customers that may have received product. Firm will replace any discarded inventory. Questions or concerns can be directed to: 1-800-638-8663.
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in
Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented
Infraredx, Inc. sent an Urgent Product Recall Medical Device Field Correction letter dated December 15, 2016, describing the problem and replacing the defective lasers. A Field Service Representative will contact customers to schedule a replacement of the system's laser rack module. If customers receive this letter and are not contacted within 48 hours, please call Infraredx Technical Support@ 1-800-596-3104. For questions regarding this recall call 781-221-0053.
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint con
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
Urgent Field safety notice was distributed to customers on November 24, 2017 via e-mail. The letter identified the affected product, problem and actions to be taken. For further questions, please call (949) 328-3366.
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
Potential breach of sterility of the packaging.
A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.
Custom Made Implant System with Minimum Invasive Grower (MIG) component
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
On December 21, 2017 a FIELD SAFETY NOTICE was issued to customers notifying of the corrective action. An attachment was supplied with the letter titled "Minimally Invasive Grower - Instructions For Adjustment that is effective on and after October 14, 2014. Questions or concerns can be directed to your local sales representative.
The GC80 Digital X-ray Imaging System
An image was obtained with over exposure during a Thorax examination using the AEC function.
On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.