BEUDAMED
    FDA Recall Terminated

    Isulin Pump. Model IR1250

    Recall: Z-0309-06 · Initiated October 31, 2005

    Recall

    Recall Number
    Z-0309-06
    Event Number
    33950
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2005
    Posted
    December 23, 2005
    Terminated
    December 23, 2005
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    Isulin Pump. Model IR1250

    Reason

    Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

    Action

    The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.

    Distribution

    The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.

    Quantity

    2 units