Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Reported: March 6, 2024 Initiated: January 19, 2024 #Z-1198-2024
Product Description
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Reason for Recall
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.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 161 units
- Distribution
- 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).
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.. Recalled by Integra LifeSciences Corp.. Units affected: 161 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Moderate. Recall number: Z-1198-2024.
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