BEUDAMED
    FDA Recall Terminated

    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

    Recall: Z-0493-05 · Initiated December 16, 2004

    Recall

    Recall Number
    Z-0493-05
    Event Number
    30711
    Firm
    Ethicon, Inc US
    FEI Number
    2210968
    Product Code
    HIH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 16, 2004
    Posted
    February 2, 2005
    Terminated
    October 31, 2005
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

    Reason

    Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.

    Action

    The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.

    Distribution

    Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.

    Quantity

    891electrodes