BEUDAMED
    FDA Enforcement Class II Terminated

    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

    Recall: Z-0055-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0055-2020
    Event ID
    82851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    May 13, 2019
    Classification Date
    October 7, 2019
    Termination Date
    August 6, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

    Reason

    Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

    Code Info

    Lot Number/UDI: 811767N (01)30382903659655 (17)190930(10)811767N(30)50 (17)190930(10)811767N(30)200 (01)50382903659659 2019-09-30 815066N (01)30382903659655 (17)191130(10)815066N(30)50 (17)191130(10)815066N(30)200 (01)50382903659659 821471N (01)30382903659655 (17)200131(10)821471N(30)50 (17)200131(10)821471N(30)200 (01)50382903659659 821990N (01)30382903659655 (17)200131(10)821990N(30)50 (17)200131(10)821990N(30)200 (01)50382903659659

    Distribution

    Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN

    Quantity

    N/A