BEUDAMED
    FDA Recall Terminated

    Animas IR 1250 Insulin Pump.

    Recall: Z-0929-05 · Initiated April 11, 2005

    Recall

    Recall Number
    Z-0929-05
    Event Number
    31760
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2005
    Posted
    June 25, 2005
    Terminated
    January 24, 2006
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Animas IR 1250 Insulin Pump.

    Reason

    pump failed to respond to keypad button pressess after using the food database feature

    Action

    The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.

    Distribution

    The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.

    Quantity

    2081 units