BEUDAMED
    FDA Recall Terminated

    One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.

    Recall: Z-2639-2010 · Initiated January 7, 2010

    Recall

    Recall Number
    Z-2639-2010
    Event Number
    54382
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 7, 2010
    Posted
    October 1, 2010
    Terminated
    March 14, 2011
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035

    Description

    One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.

    Reason

    One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.

    Action

    Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.

    Distribution

    Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.

    Quantity

    9631 cartons, 4 vials per carton