FDA Enforcement
Class II
Ongoing
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Recall: Z-1199-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1199-2024
- Event ID
- 93881
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- January 19, 2024
- Classification Date
- February 28, 2024
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650, United States
Description
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
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 Info
UDI: 10381780431930 Lot Number: 7257036 Exp: Date: 1-Sep-24
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).
Quantity
30 units