Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-1198-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Class II
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.
UDI:10381780431923 Lot Number: 7124720 Exp Date: 1-Sep-24
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).
Voluntary: Firm initiated
