BEUDAMED
    FDA Enforcement Class III Terminated

    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.

    Recall: Z-2434-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2434-2015
    Event ID
    71633
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    June 23, 2015
    Classification Date
    August 20, 2015
    Termination Date
    April 6, 2016
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.

    Reason

    Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.

    Code Info

    REF #367986, Lot #'s 5133957 and 5133959

    Distribution

    Distributed in FL, IL, MA, MI, MO, PA and TN.

    Quantity

    238, 000 (Lot #5133959) and 243,000 (Lot #5133957)