BEUDAMED
    FDA Recall Terminated

    BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

    Recall: Z-0957-2007 · Initiated May 17, 2007

    Recall

    Recall Number
    Z-0957-2007
    Event Number
    37953
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2007
    Posted
    June 21, 2007
    Terminated
    August 15, 2007
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

    Reason

    Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

    Action

    Product Recall letters dated May 1, 2007. were sent to all distributors by first class mail. The letter requested all distributors to examine inventory for specific catalog and lot numbers. It also requested distributors to send a copy of the enclosed customer letter to all customers as a subrecall. BD has contracted a third party (West Inc., Appleton, Wisconsin) to coordinate the mailing to all customers, if the firm chooses to use the third party, or the distributor can send the letters themselves.

    Distribution

    Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

    Quantity

    142,800 worldwide