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FDAOctober 19, 2023device

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

integra lifesciencesintegra

UPCs

10381780263906

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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