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Recall Observatory FDA recall evidence

Device product

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

Z-0416-2016

November 19, 2015

Class II

Product summary

Firm
Cook Inc.
Event
Event 72718
Status
Terminated
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-0416-2016

Official wording

Reason: 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.

Code information: Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X

Distribution pattern: Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.