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FDAJanuary 19, 2024device

INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

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

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

integra lifesciencesintegra

UPCs

10381780431947

Recall history

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

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