BEUDAMED
    FDA Enforcement Class II Terminated

    Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

    Recall: Z-1034-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1034-2015
    Event ID
    69299
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Animas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    September 6, 2011
    Classification Date
    January 30, 2015
    Termination Date
    August 10, 2015
    Address
    200 Lawrence Dr, N/A, West Chester, PA, 19380-3428, United States

    Description

    Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

    Reason

    Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.

    Code Info

    Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63

    Distribution

    No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

    Quantity

    1235