Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu
Summary
The FDA issued a Class II for Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during by Integra LifeSciences Corp.. Reason: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device..
Details
Source
Device Recall
External ID
Z-1873-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Lot/Code Info: UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025
Quantity Affected: 1,822 units
Reason for Recall
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Distribution
Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-17
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 291 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-1873-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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