BEUDAMED
    FDA Enforcement Class II Terminated

    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

    Recall: Z-2259-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2259-2018
    Event ID
    79901
    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
    June 27, 2018
    Initiation Date
    April 11, 2018
    Classification Date
    June 20, 2018
    Termination Date
    May 10, 2019
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

    Reason

    Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.

    Code Info

    All lots

    Distribution

    US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.

    Quantity

    N/A