Z-2224-2021 Class II Terminated
FDA device recall Z-2224-2021 was initiated by Integra LifeSciences Corp. on June 1, 2021 and is designated Class II. Reason for recall: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier The recall status is terminated (terminated January 27, 2023). Affected quantity: 906 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 1, 2021
- Termination Date
- January 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 906 units
Product Description
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Reason for Recall
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Distribution Pattern
US Nationwide Distribution - Foreign Distribution: Hong Kong
Code Information
Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625