Codman Raney Scalp Clips recalled for compromised sterile barrier packaging
Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries have been reported, and the hazard—compromised sterile barrier—is theoretical in this case. This falls under 'risk-of-harm products where injury has not yet been reported,' warranting a severity score of 3.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Raney Scalp Clips (Part Number 201037) distributed nationwide in the United States and to Hong Kong. A total of 906 units are affected.
The recall is due to a packaging defect. The pouches containing these disposable surgical clips have wrinkles across the Tyvek side of the packaging. These wrinkles may compromise the integrity of the sterile barrier that protects the device.
These clips are disposable cylindrical devices designed to provide hemostasis (stop bleeding) at scalp wound edges during surgery. If the sterile barrier is compromised, the clips may no longer be sterile when opened for use.
The affected lot numbers are W2102045, W2102046, W2102048, and W2102049 (GTIN# 10381780511625).
The recalled product
- Product
- CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 906
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: W2102045
- W2102046
- W2102048 and W2102049 GTIN# 10381780511625
Distribution
Distributed nationwide across the United States.
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