BEUDAMED
    FDA Enforcement Class II Terminated

    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

    Recall: Z-0585-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0585-2017
    Event ID
    75428
    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 12, 2016
    Classification Date
    November 16, 2016
    Termination Date
    October 5, 2021
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

    Reason

    Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

    Code Info

    Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854

    Distribution

    FL, GA, LA, OH, VA and WA.

    Quantity

    70 units