BEUDAMED
    FDA Recall Terminated

    ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.

    Recall: Z-2822-2015 · Initiated June 12, 2015

    Recall

    Recall Number
    Z-2822-2015
    Event Number
    72106
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    MUU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 12, 2015
    Posted
    September 30, 2015
    Terminated
    May 23, 2016
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.

    Reason

    There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.

    Action

    The firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.

    Distribution

    Nationwide Distribution.

    Quantity

    168, ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump