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Terminated

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

FDA Recall Z-0416-2016 · Posted 2015-12-14

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeNHC
Date Initiated2015-11-19
Date Terminated2017-02-22
Product Quantity35

Reason for Recall

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.

Firm Action

Cook Medical issued letter via certified mail on 11/19/2015, for their voluntary recall of the VentriClear II Ventricular Drainage Catheter Set due to being sterilized twice. The Distributor was instructed to forward the recall letter on to its customers, and quarantine any unused recalled devices, and return them to Cook Medical. Customers with questions may contact: Cook Medical Customer Relations 1-800-457-4500 or 1-812-339-2235. Monday through Friday between 7:30a.m. and 5:00p.m. Eastern Daylight Time or email at [email protected].

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071640VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRMCook, Inc. · 2007-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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