Reported May 29, 2024 · Ongoing
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure
- Catalog NumberINS5HND
- Lot codes and dates
- UDI-DI10381780263906 Lot Number/Exp
- Date
7257032 07/16/20257275713 09/03/20257291974 09/03/20257312131 09/03/20257289690 09/03/20257291975 09/03/20257312137 09/03/2025 7312139 09/03/2025
- Amount recalled
- 1,822 units
Where it was sold
- Nationwide
- CA
Why it was recalled
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
This product could cause temporary or reversible health problems — stop using it.
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