BEUDAMED
    FDA Enforcement Class II Terminated

    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

    Recall: Z-0060-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0060-2020
    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 PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

    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: 819352N (01)30382903659877 (17)190930(10)819352N(30)50 (17)190930(10)819352N(30)200(01)50382903659871 822851N (01)30382903659877 (17)191031(10)822851N(30)50 (17)191031(10)822851N(30)200(01)50382903659871 822852N (01)30382903659877 (17)191031(10)822852N(30)50 (17)191031(10)822852N(30)200(01)50382903659871 822853N (01)30382903659877 (17)191031(10)822853N(30)50 (17)191031(10)822853N(30)200(01)50382903659871 822854N (01)30382903659877 (17)191031(10)822854N(30)50 (17)191031(10)822854N(30)200(01)50382903659871 822855N (01)30382903659877 (17)191031(10)822855N(30)50 (17)191031(10)822855N(30)200(01)50382903659871 822862N (01)30382903659877 (17)191031(10)822862N(30)50 (17)191031(10)822862N(30)200(01)50382903659871 824092N (01)30382903659877 (17)191031(10)824092N(30)50 (17)191031(10)824092N(30)200(01)50382903659871 826768N (01)30382903659877 (17)191130(10)826768N(30)50 (17)191130(10)826768N(30)200(01)50382903659871 827652N (01)30382903659877 (17)191231(10)827652N(30)50 (17)191231(10)827652N(30)200(01)50382903659871 827753N (01)30382903659877 (17)191231(10)827753N(30)50 (17)191231(10)827753N(30)200(01)50382903659871 827754N (01)30382903659877 (17)191231(10)827754N(30)50 (17)191231(10)827754N(30)200(01)50382903659871

    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