Pilling Wecksorb Cylindrical Sponges
FDA device recall Z-0772-2023 · posted 2022-12-28 · Open, Classified
Recall details
- Recalling firm
- TELEFLEX LLC
- Reason for recall
- Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- EFQ
- Quantity affected
- 1,000 units
- Distribution
- Domestic distribution to IL, MS, PA, TN.
- Date initiated
- 2022-09-28
- Date posted
- 2022-12-28
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROLOGICAL SPONGES (PATTIES) (K791871) | Carwild Corp. | 1979-11-05 |