Integra LifeSciences Corp.: Ref No: INSHITH / 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: 8906 units Lot/code info: UDI: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 6788598 1-Sep-23 6788599 1-Dec-23 6788600 1-Jan-24 6896383 1-Dec-23 6896384 1-Jan-24 6896385 1-Jan-24 6955153 17-Mar-24 6955154 17-Mar-24 6955155 17-Mar-24 7000260 17-Mar-24 7000261 17-Mar-24 7000262 17-Mar-24 7028225 17-Mar-24 7028226 17-Mar-24 7028227 1-Apr-24 7073035 1-Apr-24 7073036 1-Apr-24 7073037 1-Apr-24 7124699 1-Apr-24 7124700 1-Apr-24 7124702 1-Apr-24 7249008 1-Jun-24 7249009 1-Jun-24 7257038 1-Jun-24 7257039 1-Jun-24 7257040 1-Jun-24

UPC codes

10381780263968

Source

Official record: FDA (Device enforcement) ↗

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