BEUDAMED
    FDA Recall Terminated

    IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.

    Recall: Z-0211-05 · Initiated September 28, 2004

    Recall

    Recall Number
    Z-0211-05
    Event Number
    30166
    Firm
    Animas Corporation
    FEI Number
    3002920072
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2004
    Posted
    November 19, 2004
    Terminated
    March 10, 2005
    Address
    200 Lawrence Dr, West Chester, PA, 19380-3428

    Description

    IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.

    Reason

    Suspend mode not functioning properly

    Action

    The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem.

    Distribution

    The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel.

    Quantity

    7395 units