Device product
Pilling Wecksorb Cylindrical Sponges
Z-0772-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 91312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,000 units
- Official record key
device-enforcement:Z-0772-2023
Official wording
Reason: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Code information: Catalog Number: 200400, Lot Number: 22B0395
Distribution pattern: Domestic distribution to IL, MS, PA, TN.
Derived failure modes
-
Unknown
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.