BEUDAMED
    FDA Recall 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 · Initiated March 27, 2013

    Recall

    Recall Number
    Z-1319-2013
    Event Number
    65034
    Firm
    Summit Medical, Inc.
    FEI Number
    3008719017
    Product Code
    JYO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 27, 2013
    Posted
    May 14, 2013
    Terminated
    August 6, 2013
    Address
    815 Northwest Pkwy, Ste 100, Eagan, MN, 55121-1658

    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).

    Action

    Summit Medical sent a Medical Device Recall letter dated March 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately examine your inventory, and quarantine the product subject to this recall. Please complete and return the enclosed "Recall Response Form" as soon as possible. The fax number is (651) 789-3961. For further questions please call (651) 789-3921.

    Distribution

    Distributed in MS, NY, PA and TX.

    Quantity

    9 boxes