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Recall Observatory FDA recall evidence

Device product

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

Z-0497-2024

October 19, 2023

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 93356
Status
Ongoing
Classification
Class II
Quantity
160 units
Official record key
device-enforcement:Z-0497-2024

Official wording

Reason: 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

Code information: UDI-DI: 10381780263876 Lot Number/Exp. Date: 6844180 1-Dec-23; 7028238 1-Jan-24; 7078247 17-Mar-24 7248995 1-Jun-24

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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