Integra LifeSciences Corp.: Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06

Hazard

Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

Details from the source

Reason for recall: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom. Quantity: 160 units Lot/code info: UDI-DI: 10381780263876 Lot Number/Exp. Date: 6844180 1-Dec-23; 7028238 1-Jan-24; 7078247 17-Mar-24 7248995 1-Jun-24

UPC codes

10381780263876

Source

Official record: FDA (Device enforcement) ↗

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