BEUDAMED
    FDA Enforcement Class II 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 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0416-2016
    Event ID
    72718
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2015
    Initiation Date
    November 19, 2015
    Classification Date
    December 14, 2015
    Termination Date
    February 22, 2017
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    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.

    Code Info

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

    Distribution

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

    Quantity

    35