Recall Z-0772-2023 ยท EFQ Gauze/Sponge, Internal
TELEFLEX LLC
Pilling Wecksorb Cylindrical Sponges
| Date | Dec 28, 2022 (initiated Sep 28, 2022) |
| Status | Terminated |
| Reason | Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised. |
| Root 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 | 1,000 units |
| Distribution | Domestic distribution to IL, MS, PA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791871 | NEUROLOGICAL SPONGES (PATTIES) Carwild Corp., Nov 5, 1979 |