Integra LifeSciences Corp.: Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

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.

Details from the source

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: 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: 188 units Lot/code info: UDI:10381780431916 Lot Number: 7124718 Exp Date: 1-Sep-24

UPC codes

10381780431916

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.