Device product
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Z-1552-2022
Product summary
- Event
- Event 90668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1552-2022
Official wording
Reason: The sterile barrier may be compromised.
Code information: SKU/Part Number: ZZ-0697; Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970
Distribution pattern: US Nationwide distribution in the state of SC.
Derived failure modes
-
Sterility assurance
sterile barrier may be compromised