BEUDAMED
    FDA Recall Terminated

    LifeScan OneTouch SureSoft Lancing Device, single use lancing device.

    Recall: Z-0271-06 · Initiated October 11, 2005

    Recall

    Recall Number
    Z-0271-06
    Event Number
    33941
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 11, 2005
    Posted
    December 8, 2005
    Terminated
    November 21, 2006
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    LifeScan OneTouch SureSoft Lancing Device, single use lancing device.

    Reason

    In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.

    Action

    On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.

    Quantity

    1123 boxes