BEUDAMED
    FDA Recall Terminated

    E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    Recall: Z-2097-2013 · Initiated August 7, 2013

    Recall

    Recall Number
    Z-2097-2013
    Event Number
    65995
    Firm
    Megadyne Medical Products, Inc.
    FEI Number
    1721194
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 7, 2013
    Posted
    August 27, 2013
    Terminated
    January 28, 2014
    Address
    11506 South State Street, Draper, UT, 84020-9453

    Description

    E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    Reason

    Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.

    Action

    Megadyne sent an Urgent: Medical Device Recall Field Safety Notice dated August 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were also notified with follow-up phone calls and email beginning on August 7, 2013. Customers were instructed to examine their stock immediately to determine if you have any of the products from the affected lots on hand. If so, please remove form service/discontinue use and contact Megadyne Customer Service at 1 (801) 576-9669 or (800) 747-6110 (USA) for return authorization and replacement or credit.

    Distribution

    Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA.

    Quantity

    1816