BEUDAMED
    FDA Recall Terminated

    WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.

    Recall: Z-2759-2016 · Initiated August 24, 2016

    Recall

    Recall Number
    Z-2759-2016
    Event Number
    75020
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 24, 2016
    Posted
    September 8, 2016
    Terminated
    August 25, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.

    Reason

    Misbranded: Incorrect etching on the device.

    Action

    Teleflex sent an Urgent Medical Device Notification letter dated August 24, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. For questionscontact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.

    Quantity

    49 units