BEUDAMED
    FDA Recall Terminated

    Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.

    Recall: Z-1223-04 · Initiated May 17, 2004

    Recall

    Recall Number
    Z-1223-04
    Event Number
    28917
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2004
    Posted
    July 20, 2004
    Terminated
    May 10, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.

    Reason

    Lack of assurance of sterility.

    Action

    The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.

    Distribution

    Worldwide.