Integra LifeSciences Corp. 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0491-2024
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the… Recall
Issued December 13, 2023 · Integra LifeSciences Corp.
In December 2023, Integra LifeSciences Corp. recalled the Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Integra LifeSciences Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Integra LifeSciences Corp.
- Category
- Health
- Recall date
- December 13, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Af
- Recall number
- FDA-Z-0491-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Integra LifeSciences Corp. has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.