BEUDAMED
    FDA Recall Terminated

    E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    Recall: Z-0486-2010 · Initiated October 13, 2009

    Recall

    Recall Number
    Z-0486-2010
    Event Number
    53555
    Firm
    Megadyne Medical Products, Inc.
    FEI Number
    1721194
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 13, 2009
    Posted
    December 3, 2009
    Terminated
    February 17, 2010
    Address
    11506 S State St, Draper, UT, 84020-9453

    Description

    E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    Reason

    Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.

    Action

    A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.

    Distribution

    Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.

    Quantity

    324 units