Class 2 Device Recall Pilling Wecksorb

• Date Initiated by Firm: September 28, 2022
• Date Posted: December 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0772-2023
• Recall Event ID: 91312
• 510(K)Number: K791871
• Product Classification: Gauze/sponge, internal - Product Code EFQ
• Product: Pilling Wecksorb Cylindrical Sponges
• Code Information: Catalog Number: 200400, Lot Number: 22B0395
• Recalling Firm/ Manufacturer: TELEFLEX LLC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
• Quantity in Commerce: 1,000 units
• Distribution: Domestic distribution to IL, MS, PA, TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = EFQ