BEUDAMED
    FDA Recall Terminated

    The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor); 32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202 (Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001 (BD Logic Blood Glucose Monitor).

    Recall: Z-0764-04 · Initiated January 29, 2004

    Recall

    Recall Number
    Z-0764-04
    Event Number
    28391
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 29, 2004
    Posted
    July 20, 2004
    Terminated
    October 29, 2004
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor); 32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202 (Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001 (BD Logic Blood Glucose Monitor).

    Reason

    39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

    Action

    Trade and health care professionals were sent recalled letters dated 1/29/2004.

    Distribution

    The product was shipped nationwide to 28 Wholesalers, 15 retail pharmacies and pharmacy chains, 18 managed markets/Mail order facilities, and 616 health care professionals. There are 29 Canadian consignees.

    Quantity

    207092