BEUDAMED
    FDA Enforcement Class II Terminated

    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

    Recall: Z-0061-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0061-2020
    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 FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

    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: 8212777 (01)30382903659921 (17)191031(10)8212777(30)50 (17)191031(10)8212777(30)200(01)50382903659925 8212785 (01)30382903659921 (17)191031(10)8212785(30)50 (17)191031(10)8212785(30)200(01)50382903659925 8268546 (01)30382903659921 (17)191130(10)8268546(30)50 (17)191031(10)8268546(30)200(01)50382903659925 8268549 "(01)30382903659921 (17)191130(10)8268549(30)50 (17)191130(10)8268549(30)200(01)50382903659925

    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