BEUDAMED
    FDA Recall Terminated

    OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

    Recall: Z-0630-03 · Initiated January 13, 2003

    Recall

    Recall Number
    Z-0630-03
    Event Number
    25381
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 13, 2003
    Posted
    March 12, 2003
    Terminated
    August 21, 2003
    Address
    1000 Gibraltar Drive, Milpitas, CA, 95035-6312

    Description

    OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

    Reason

    The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.

    Action

    Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.

    Distribution

    Distribution of the product is worldwide and nationwide. Distribution in the United States was between April/02 to June/02. U.S. Government/Military or Canadian distribution is unknown at this time.

    Quantity

    3,679,000 units