FDAClass IIAugust 18, 2021

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips recall: Sterility Concern

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037

Why was CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips recalled?

Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625

Product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Recalling firm
Integra LifeSciences Corp.
Quantity
906 units
Distribution
US Nationwide Distribution - Foreign Distribution: Hong Kong
Recall date
August 18, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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