BEUDAMED
    FDA Recall Terminated

    Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.

    Recall: Z-1413-06 · Initiated July 13, 2006

    Recall

    Recall Number
    Z-1413-06
    Event Number
    35771
    Firm
    Disetronic Medical Systems, Inc.
    FEI Number
    1000116163
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 13, 2006
    Posted
    September 12, 2006
    Terminated
    November 5, 2007
    Address
    11800 Exit 5 Parkway, Suite 120, Fishers, IN, 46038

    Description

    Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.

    Reason

    The battery may turn the pump off without warning due to a design change in the battery.

    Action

    Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.

    Distribution

    Nationwide and Canada.

    Quantity

    6,604 packs to U.S. and Canada.