Cook Inc. recalls VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) fro…

Recall date

November 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0416-2016

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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