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Cook Inc. recalls VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) fro
Recalled December 23, 2015 · FDA recall Z-0416-2016 · Cook
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. · FDA Class II
Units
35
Sold at
Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Description
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.
Product
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →