BEUDAMED
    FDA Enforcement Class II Terminated

    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    Recall: Z-0596-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0596-2014
    Event ID
    66895
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Asante Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2014
    Initiation Date
    November 19, 2013
    Classification Date
    December 27, 2013
    Termination Date
    April 24, 2014
    Address
    352 E Java Dr, Sunnyvale, CA, 94089-1328, United States

    Description

    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). 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.

    Code Info

    Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108.

    Distribution

    Nationwide Distribution.

    Quantity

    635 kits