Integra LifeSciences Corp. 2024-03-06 Health serious FDA
Health · FDA · Recall #FDA-Z-1196-2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For… Recall
Issued March 6, 2024 · Integra LifeSciences Corp.
In March 2024, Integra LifeSciences Corp. recalled the Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
What you should do
- 1 Stop using Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For… 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
- March 6, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Isr
- Recall number
- FDA-Z-1196-2024
- 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 737th Health recall we've logged in 2024.