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FDANovember 19, 2015device

VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.

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

The hazard

Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.

What to do

FDA enforcement status: Terminated

Brands named

cook

Recall history

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

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VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain. — Recall Details · AllClear