Recall Z-2224-2021— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2021-06-01, terminated 2023-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-01
- Terminated
- 2023-01-27
- Firm location
- Princeton, NJ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.