BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0891-2013 · Initiated February 7, 2013

    Recall

    Recall Number
    Z-0891-2013
    Event Number
    64434
    Firm
    Myco Medical Supplies Inc
    FEI Number
    1000158634
    Product Code
    GDX
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 7, 2013
    Posted
    February 27, 2013
    Terminated
    July 9, 2013
    Address
    158 Towerview Ct, Cary, NC, 27513

    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.

    Action

    MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email [email protected] or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.

    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