Device product
Various eye packs, cataract packs
Z-1705-2022
Product summary
- Event
- Event 90574
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1705-2022
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) BLSE37K, 2106292, 820211, 15017475-004 2) MECA21P, 2108022, 786211, 44234851-005 3) CMEY17AD, 2108301, 760211, 15101886-004 4) CXEY80X, 2109083, 749211, 15109749-004
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.