BEUDAMED
    FDA Recall Terminated

    ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA

    Recall: Z-0284-2009 · Initiated October 9, 2008

    Recall

    Recall Number
    Z-0284-2009
    Event Number
    49606
    FEI Number
    1282497
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 9, 2008
    Posted
    November 5, 2008
    Terminated
    July 6, 2010
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA

    Reason

    Mislabeled: Package labeled as an insulin syringe for use with U-100 insulin contains an insulin syringe for use with U-40 insulin. Risk of overdose of insulin.

    Action

    Tyco Healthcare Group LP (Covidien) notified Can-Am Care, Corp. by letter sent by e-mail and by Federal Express on 10/9/08. The letter requests that they immediately inventory, quarantine any remaining stock they may have of the product, return, and notify their customers. Wal-Mart conducted a consumer mailing on October 14, 2008, and is posting placards in their stores. Can-Am Care, whose name appears on the label of the product has concurrently posted a recall notice on their website.

    Distribution

    Nationwide

    Quantity

    471,000 (4710 boxes of 100)