FDA-Device2015-12-23Class II
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Cook Inc.
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.
Sold states
Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
Affected count
35
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2016Don't want to check this manually?
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