BEUDAMED
    FDA Enforcement Class II Terminated

    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.

    Recall: Z-2192-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2192-2013
    Event ID
    66031
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 18, 2013
    Initiation Date
    July 10, 2013
    Classification Date
    September 11, 2013
    Termination Date
    March 19, 2014
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.

    Reason

    The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.

    Code Info

    REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602

    Distribution

    Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.

    Quantity

    US - 39,800 units ; Canada - 18,400 units