BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.

    Recall: Z-0968-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0968-2018
    Event ID
    79041
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    August 29, 2017
    Classification Date
    March 12, 2018
    Termination Date
    May 16, 2019
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.

    Reason

    A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.

    Code Info

    Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410

    Distribution

    Nationwide Distribution

    Quantity

    8,494,000