BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    Recall: Z-0756-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0756-2013
    Event ID
    64010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    November 12, 2012
    Classification Date
    January 31, 2013
    Termination Date
    September 6, 2013
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    Reason

    BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.

    Code Info

    Lot No. 2180434; Expiration Date: April 2013

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.

    Quantity

    2,944,700 units