BEUDAMED
    FDA Recall Terminated

    UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

    Recall: Z-0444-03 · Initiated September 5, 2002

    Recall

    Recall Number
    Z-0444-03
    Event Number
    25313
    Firm
    Safety Syringes Inc
    FEI Number
    1000220943
    Product Code
    MEG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2002
    Posted
    January 14, 2003
    Terminated
    December 3, 2003
    Address
    1939 Palomar Oaks Way, # A, Carlsbad, CA, 92009

    Description

    UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

    Reason

    Package integrity not validated. Sterility not assured.

    Action

    Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.

    Distribution

    Medical offices located in California.

    Quantity

    3300