FDAFDA · Food and drugs·Recall number Z-1203-2024
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Published March 6, 2024 · Recall initiated: January 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
- Lot
- UDI: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 6788605 1-Jan-24 6788606 1-Jan-24 6896388 17-Mar-24 6896389 1-Dec-23 6955158 17-Mar-24 6955159 17-Mar-24 7000265 17-Mar-24 7000266 17-Mar-24 7028235 17-Mar-24 7073054 17-Mar-24 7073055 1-Apr-24 7124709 1-Apr-24 7124710 1-Apr-24 7249011 1-Apr-24 7253162 1-Jun-24 7257042 1-Jun-24 7257043 1-Jun-24 7264841 1-Jun-24
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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