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FDAJanuary 21, 2022device

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614

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

The hazard

Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

UPCs

10381780520375

Recall history

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

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