BEUDAMED
    FDA Enforcement Class II Terminated

    Endotine Transbleph 3.5 (CFD-080-0167)

    Recall: Z-2294-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2294-2016
    Event ID
    74222
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    May 6, 2016
    Classification Date
    July 27, 2016
    Termination Date
    August 12, 2016
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    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).

    Code Info

    Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373

    Distribution

    The product was distributed in the United States and Sweden

    Quantity

    29