BEUDAMED
    FDA Recall Terminated

    Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

    Recall: Z-0044-2008 · Initiated September 26, 2007

    Recall

    Recall Number
    Z-0044-2008
    Event Number
    44940
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 26, 2007
    Posted
    October 18, 2007
    Terminated
    January 15, 2008
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

    Reason

    Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.

    Action

    Recall communication issued on or about 9/28/2007.

    Distribution

    Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.

    Quantity

    1,476,000 units