BEUDAMED
    FDA Recall Terminated

    Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

    Recall: Z-0673-2007 · Initiated January 19, 2007

    Recall

    Recall Number
    Z-0673-2007
    Event Number
    37600
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2007
    Posted
    March 29, 2007
    Terminated
    May 11, 2007
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

    Reason

    Pouches were not sealed prior to sterilization.

    Action

    Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.

    Distribution

    Nationwide.

    Quantity

    192 units