Integra LifeSciences Corp.: Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

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: 1639 units Lot/code info: UDI-DI:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25

UPC codes

10381780263906

Source

Official record: FDA (Device enforcement) ↗

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