BEUDAMED
    FDA Enforcement Class II Terminated

    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.

    Recall: Z-0891-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0891-2013
    Event ID
    64434
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Myco Medical Supplies Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 6, 2013
    Initiation Date
    February 7, 2013
    Classification Date
    February 27, 2013
    Termination Date
    July 9, 2013
    Address
    158 Towerview Ct, N/A, Cary, NC, 27513, United States

    Description

    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.

    Reason

    Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.

    Code Info

    Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.

    Distribution

    Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada

    Quantity

    110,768 scalpels in individual pouches