BEUDAMED
    FDA Recall Terminated

    AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.

    Recall: Z-0942-05 · Initiated June 14, 2005

    Recall

    Recall Number
    Z-0942-05
    Event Number
    32366
    Firm
    Qualitest Pharmaceuticals Inc
    FEI Number
    1039144
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 14, 2005
    Posted
    June 30, 2005
    Terminated
    May 10, 2006
    Address
    130 Vintage Drive, Huntsville, AL, 35811-8216

    Description

    AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.

    Reason

    Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.

    Action

    The firm initiated the recall on June 14, 2005 with a press release and followed with a letter initially sent via fax and then by letter requesting return of the product and posting of a copy of the press release at the retail level.

    Distribution

    Nationwide

    Quantity

    unknown