BEUDAMED
    FDA Recall Terminated

    Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

    Recall: Z-1197-03 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-1197-03
    Event Number
    26731
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    September 17, 2003
    Terminated
    March 10, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

    Reason

    Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

    Action

    An urgent product correction and removal letter dated 7/16/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.

    Distribution

    United States