Device product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Z-2224-2021
Product summary
- Event
- Event 88312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 906 units
- Official record key
device-enforcement:Z-2224-2021
Official wording
Reason: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Code information: Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625
Distribution pattern: US Nationwide Distribution - Foreign Distribution: Hong Kong
Derived failure modes
-
Sterility assurance
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile