BEUDAMED
    FDA Recall Terminated

    Endotine Transbleph 3.5 (CFD-080-0167)

    Recall: Z-2294-2016 · Initiated May 6, 2016

    Recall

    Recall Number
    Z-2294-2016
    Event Number
    74222
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    May 6, 2016
    Terminated
    August 12, 2016
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    Endotine Transbleph 3.5 (CFD-080-0167)

    Reason

    MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

    Action

    The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.

    Distribution

    The product was distributed in the United States and Sweden

    Quantity

    29