BEUDAMED
    FDA Recall 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 · Initiated October 12, 2016

    Recall

    Recall Number
    Z-0585-2017
    Event Number
    75428
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    FAS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2016
    Terminated
    October 5, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    Consignees were notified via letter on 10/12/2016.

    Distribution

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

    Quantity

    70 units