BEUDAMED
    FDA Recall Terminated

    NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)

    Recall: Z-0927-2007 · Initiated May 11, 2007

    Recall

    Recall Number
    Z-0927-2007
    Event Number
    37984
    Firm
    Hawaii Medical LLC
    FEI Number
    3003827293
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 11, 2007
    Posted
    June 9, 2007
    Terminated
    July 22, 2008
    Address
    750 Corporate Park, Pembroke, MA, 02359

    Description

    NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)

    Reason

    Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient

    Action

    Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.

    Distribution

    Nationwide

    Quantity

    58,058 units