BEUDAMED
    FDA Recall Terminated

    LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter

    Recall: Z-0272-06 · Initiated October 10, 2005

    Recall

    Recall Number
    Z-0272-06
    Event Number
    33942
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2005
    Posted
    December 8, 2005
    Terminated
    November 21, 2006
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter

    Reason

    Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters

    Action

    A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.

    Distribution

    Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution

    Quantity

    2843 kits