Z-Medica, LLC Recalls
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QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Lack of Packaging seal integrity may result in a sterile barrier breach.
Z-Medica notifed the customer via email on Wednesday 9/22/2021 and requested to place the products on hold. A formal notification letter was sent to the customer on 9/23/2021. Letter states reason for recall, health risk and action to take: We are requesting that you return all units of lot 12645 to Z-Medica, LLC ( 4 Fairfield Boulevard, Wallingford, CT 06492, ATTN: Recall - Regulatory Affairs). Please and return the attached Acknowledgement Form via email to joseph.azary@teleflex.com. If you have distributed any units of this lot number, please contact your customers and arrange for return of these units from lot 12645. Should you have any questions about this information please contact me at (203) 774-5686 or by email at joseph.azary@teleflex.com. issued Urgent Medical Device Recall letter
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
Packaging breach may compromise sterility
Z- Medica issued recall letters dated May 15, 2017, on May 17 2017, advising users of the problem and requesting customers to check their inventory and return product for replacement. Distributors requested to sub recall. Customers with questions were instructed to contact (203) 774-5686.
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).
On November 22, 2017 an URGENT ADVISORY NOTICE was issued to customers stating the following: The QuikClot TraumaPad is packaged with 10 pouches in a carton. This lot may contain some pouches that incorrectly identify the product as QuikClot Roll. All pouches (identified as TraumaPad or Roll) are identified with the correct Part N umber (REF 460), Lot Number, and Expiration Date for QuikClot TraumaPad, and contain the QuikClot TraumaPad product. Please note that the labeling on the cartons is also correct and we believe that this only impacts a small num ber of pouches. In addition, QuikClot TraumaPad and QuikCot Roll have the identical ingredients, chemical composition, indications for use, packaging material and surface area. The only difference is that the QuikClot TraumaPad is a 12 inch x 12 inch, 3-ply pad and the QuikClot Roll is a 3 inch x 4 yard roll. Both products are equally effective in being used to stop bleeding. This was the result of an isolated operator error. Please note that actions have been taken to prevent this issue in the future and further corrective actions are under review. Ifyou have any inventory of this lot number, you may choose to use the prod uct as the correct prod uct is packaged into each pouch (only pouch labeling is incorrect). Ifyou chose to destroy the prod uct or have any questions regardi ng this matter, please contact us at the email and telephone number below.