Device product
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Z-1197-2024
Product summary
- Event
- Event 93881
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 188 units
- Official record key
device-enforcement:Z-1197-2024
Official wording
Reason: 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.
Code information: UDI:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24
Distribution pattern: 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).
Derived failure modes
-
Unknown
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.