Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:
Summary
The FDA issued a Class II for Integra Cranial Access Kit-For access to the subarachnoid space or the lateral v by Integra LifeSciences Corp.. Reason: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the ster.
Details
Source
Device Recall
External ID
Z-0495-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Lot/Code Info: UDI-DI: 10381780431923 Lot Number/Exp. Date: 6561324 1-Aug-24 6844177 1-Mar-25 7078242 1-May-25
Quantity Affected: 510 units
Reason for Recall
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-19
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 197 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-0495-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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