Reported Mar 6, 2024 · Ongoing
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the…
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?
- Ref NoINSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain
- Lot codes and dates
- UDI10381780263968
- Lot Number ExpDate:
66316031-Sep-2366316041-Sep-2367102121-Sep-2367102131-Sep-2367885981-Sep-2367885991-Dec-2367886001-Jan-2468963831-Dec-2368963841-Jan-2468963851-Jan-24695515317-Mar-24695515417-Mar-24695515517-Mar-24700026017-Mar-24700026117-Mar-24700026217-Mar-24702822517-Mar-24702822617-Mar-2470282271-Apr-2470730351-Apr-2470730361-Apr-2470730371-Apr-2471246991-Apr-2471247001-Apr-2471247021-Apr-2472490081-Jun-2472490091-Jun-2472570381-Jun-2472570391-Jun-2472570401-Jun-24
- Amount recalled
- 8906 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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