Device product
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Z-2520-2025
Product summary
- Firm
- O&M HALYARD INC
- Event
- Event 97394
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1316
- Official record key
device-enforcement:Z-2520-2025
Official wording
Reason: Surgical drape packs may have open seals, which may compromise the sterility of the product.
Code information: Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
Distribution pattern: Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Derived failure modes
-
Sterility assurance
seals, which may compromise the sterility