BEUDAMED
    FDA Recall Terminated

    ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.

    Recall: Z-1226-2007 · Initiated June 21, 2007

    Recall

    Recall Number
    Z-1226-2007
    Event Number
    38399
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2007
    Posted
    September 20, 2007
    Terminated
    June 3, 2008
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.

    Reason

    Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

    Action

    Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.

    Distribution

    Nationwide.

    Quantity

    644,500 units