FDA Enforcement
Class II
Terminated
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Recall: Z-2224-2021
·
Reported August 18, 2021
Enforcement
- Recall Number
- Z-2224-2021
- Event ID
- 88312
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 18, 2021
- Initiation Date
- June 1, 2021
- Classification Date
- August 6, 2021
- Termination Date
- January 27, 2023
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Reason
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Code Info
Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625
Distribution
US Nationwide Distribution - Foreign Distribution: Hong Kong
Quantity
906 units