CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Numb
Summary
The FDA issued a Class II for CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemost by Integra LifeSciences Corp.. Reason: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier.
Details
Source
Device Recall
External ID
Z-2224-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Lot/Code Info: Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625
Quantity Affected: 906 units
Reason for Recall
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Distribution
US Nationwide Distribution - Foreign Distribution: Hong Kong
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-01
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2224-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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