BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0416-2016 · Initiated November 19, 2015

    Recall

    Recall Number
    Z-0416-2016
    Event Number
    72718
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    NHC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 19, 2015
    Posted
    December 14, 2015
    Terminated
    February 22, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

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

    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.

    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].

    Distribution

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

    Quantity

    35