Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. 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 information: UDI: 10381780263975 Lot Number Exp: Date: 6710227 30-Jun-24 6788602 30-Jun-24 6955170 7-Feb-25 7000268 7-Feb-05 7028247 10-Apr-25 7078234 11-May-25 7249010 18-Jul-25 7253163 22-Jun-25

Distribution pattern: 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).