BEUDAMED
    FDA Enforcement Class II Terminated

    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    Recall: Z-0406-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0406-2017
    Event ID
    75492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 13, 2016
    Classification Date
    November 14, 2016
    Termination Date
    February 10, 2022
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

    Reason

    Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

    Code Info

    Product Codes: REK32N and FEK32HW.

    Distribution

    U.S. Nationwide.

    Quantity

    75,089 units