—#197431

Product

Pilling Wecksorb Cylindrical Sponges

FDA product code: EFQ — Gauze/Sponge, Internal
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K791871
Affected lot / code info: Catalog Number: 200400, Lot Number: 22B0395

Why it was recalled

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: TELEFLEX LLC
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: Domestic distribution to IL, MS, PA, TN.

Timeline

Recall initiated: 2022-09-28
Posted by FDA: 2022-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197431. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.