BEUDAMED
    FDA Recall Terminated

    OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels

    Recall: Z-2835-2011 · Initiated May 27, 2011

    Recall

    Recall Number
    Z-2835-2011
    Event Number
    59078
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    F
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 27, 2011
    Posted
    July 15, 2011
    Terminated
    January 5, 2012
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035

    Description

    OneTouch Delica Lancing Device; LifeScan Inc., Milpitas, CA Testing of Blood Glucose Levels

    Reason

    Individuals attempting to remove a lancet from the OneTouch Delica lancing device without following instructions for use may experience an accidental needle stick.

    Action

    Lifescan sent an Urgent Medical Device Correction letter dated May 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told that no action on their part is needed and were asked not to return any of the affected product. Customers were instructed to continue to distribute the product. Healthcare professionals and pharmacies were asked to share the information with their patients who use the OneTouch Delica Lancing Device. Patients with questions should contact Customer Care Line at 1-800-574-6138. For questions regarding this recall call 1-800-600-7226.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    1,032,515 in US