BEUDAMED
    FDA Recall Terminated

    NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.

    Recall: Z-0624-03 · Initiated August 15, 2002

    Recall

    Recall Number
    Z-0624-03
    Event Number
    25039
    Firm
    E Med Future Inc
    FEI Number
    3003763354
    Product Code
    MTV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2002
    Posted
    March 6, 2003
    Terminated
    February 5, 2004
    Address
    794 Morrison Road, Columbus, OH, 43230

    Description

    NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.

    Reason

    Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.

    Action

    On 8/15/2002, the firm contacted their largest distributor by telephone and instructed them to stop distribution and to place all remaining devices in quarantine until further notice. On 3/20/2003, the firm mailed recall notices to all direct accounts asking for the device to be returned.

    Distribution

    The devices were shipped to customers located nationwide. The product was also distributed into Canada, Greece and Ireland.

    Quantity

    1,572 devices