BEUDAMED
    FDA Recall Terminated

    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

    Recall: Z-0597-2014 · Initiated November 19, 2013

    Recall

    Recall Number
    Z-0597-2014
    Event Number
    66895
    Firm
    Asante Solutions, Inc.
    FEI Number
    3009351200
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 19, 2013
    Posted
    December 27, 2013
    Terminated
    April 24, 2014
    Address
    352 E Java Dr, Sunnyvale, CA, 94089-1328

    Description

    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

    Reason

    Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

    Action

    Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.

    Distribution

    Nationwide Distribution.

    Quantity

    352