BEUDAMED
    FDA Recall Terminated

    OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA

    Recall: Z-1070-2009 · Initiated November 25, 2008

    Recall

    Recall Number
    Z-1070-2009
    Event Number
    50471
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 25, 2008
    Posted
    March 17, 2009
    Terminated
    December 6, 2010
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035

    Description

    OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA

    Reason

    Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.

    Action

    Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.

    Distribution

    Worldwide Distribution -- USA and the Caribbean.

    Quantity

    23,288 vials