Device product
Various ob/gyn packs
Z-1701-2022
Product summary
- Event
- Event 90574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1701-2022
Official wording
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Code information: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSROBDELIVC, 2104091, 904211, 14531604 2) LSRVAGDELIVC, 2106011, 863211, 44252284 3) LSRVAGDELIVC, 2106011, 863211, 44135283 4) LSRCFHVAGDC, 2108042, 791211, 64123598 5) LSRCFHVAGDC, 2108042, 791211, 64123599 6) LSRCFHVAGDC, 2108042, 791211, 64123597 7) LSRVAGDELIVC, 2108181, 776211, 44139780 8) LSROBDELIVC, 2109231, 743211, 64319309 9) UPVD01G, 2109211, 741211, 15187693 10) MEVG08P, 2105132, 873211, 14874335-004 11) SLOB77F, 2108101, 779211, 15093748-004 12) MEVG08Q, 2108192, 770211, 15103947-004 13) BHVG89C, 2104291, 887211, 14962314-004 14) BHVG89C, 2106303, 827211, 14956518-004 15) AGOB35D, 2107221, 799211, 64183198-006
Distribution pattern: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Derived failure modes
-
Unknown
Product was exposed to multiple sterilization cycles without validation for multiple exposures.