BEUDAMED
    FDA Recall Terminated

    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

    Recall: Z-1524-2013 · Initiated April 16, 2013

    Recall

    Recall Number
    Z-1524-2013
    Event Number
    65046
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2013
    Posted
    June 8, 2013
    Terminated
    January 30, 2014
    Address
    1625 W 3rd St, Ste 109, Tempe, AZ, 85281-2438

    Description

    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

    Reason

    Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.

    Action

    Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.

    Distribution

    Worldwide Distribution: USA Nationwide and Internationally to Europe.

    Quantity

    3,085