Z-1197-2024 Class II Ongoing
FDA device recall Z-1197-2024 was initiated by Integra LifeSciences Corp. on Jan 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 188 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2024
- Initiation Date
- Jan 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product Description
Ref No: INS7250 / 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.
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).
Code Information
UDI:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1197-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026