Device product
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Z-1553-2022
Product summary
- Event
- Event 90668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 825 units
- Official record key
device-enforcement:Z-1553-2022
Official wording
Reason: The sterile barrier may be compromised.
Code information: SKU/Part Number: ZZ-0700; Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000
Distribution pattern: US Nationwide distribution in the state of SC.
Derived failure modes
-
Sterility assurance
sterile barrier may be compromised