BEUDAMED
    FDA Enforcement Class II Terminated

    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    Recall: Z-0600-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0600-2014
    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 Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; 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-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers: 0230128 5005803 5030168.

    Distribution

    Nationwide Distribution.

    Quantity

    454 kits