BEUDAMED
    FDA Recall Terminated

    One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200

    Recall: Z-1165-2007 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-1165-2007
    Event Number
    38035
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 30, 2007
    Posted
    August 16, 2007
    Terminated
    December 3, 2007
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6312

    Description

    One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200

    Reason

    Lancet tip may not fully retract and cause needle stick and exposure to used lancets.

    Action

    The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.

    Distribution

    Product was distributed nationwide to distributors and wholesale dealers.

    Quantity

    632 cartons (200 units per carton)