BEUDAMED
    FDA Recall Terminated

    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.

    Recall: Z-0279-2016 · Initiated October 26, 2015

    Recall

    Recall Number
    Z-0279-2016
    Event Number
    72552
    Firm
    Astora
    FEI Number
    3011770902
    Product Code
    PAH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 26, 2015
    Posted
    November 16, 2015
    Terminated
    March 9, 2016
    Address
    13200 Pioneer Trl, Eden Prairie, MN, 55347-4119

    Description

    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.

    Reason

    The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.

    Action

    Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.

    Distribution

    Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX

    Quantity

    52