BEUDAMED
    FDA Enforcement Class II Terminated

    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.

    Recall: Z-1319-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1319-2013
    Event ID
    65034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Summit Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    March 27, 2013
    Classification Date
    May 14, 2013
    Termination Date
    August 6, 2013
    Address
    815 Northwest Pkwy Ste 100, Eagan, MN, 55121-1658, United States

    Description

    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.

    Reason

    Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).

    Code Info

    Lot No. 121012

    Distribution

    Distributed in MS, NY, PA and TX.

    Quantity

    9 boxes