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Recall Observatory FDA recall evidence

Device product

Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004

Z-0499-2024

October 19, 2023

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 93356
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0499-2024

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: 10381780178095 Lot Number/Exp. Date: 6926457 31-May-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