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Recall Observatory FDA recall evidence

Device product

Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Z-1198-2024

January 19, 2024

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 93881
Status
Ongoing
Classification
Class II
Quantity
161 units
Official record key
device-enforcement:Z-1198-2024

Official wording

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:10381780431923 Lot Number: 7124720 Exp Date: 1-Sep-24

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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.