BEUDAMED
    FDA Enforcement Class II Terminated

    BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

    Recall: Z-0059-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0059-2020
    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 PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

    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: 808592N (01)30382903659853 (17)190630(10)808592N(30)50 (17)190630(10)808592N(30)200(01)50382903659857 809669N (01)30382903659853 (17)190630(10)809669N(30)50 (17)190630(10)809669N(30)200(01)50382903659857 811070N (01)30382903659853 (17)190630(10)811070N(30)50 (17)190630(10)811070N(30)200(01)50382903659857 811071N (01)30382903659853 (17)190630(10)811071N(30)50 (17)190630(10)811071N(30)200(01)50382903659857 811664N (01)30382903659853 (17)190630(10)811664N(30)50 (17)190630(10)811664N(30)200(01)50382903659857 813767N (01)30382903659853 (17)190731(10)813767N(30)50 (17)190731(10)813767N(30)200(01)50382903659857 815060N (01)30382903659853 (17)190731(10)815060N(30)50 (17)190731(10)815060N(30)200(01)50382903659857 815061N (01)30382903659853 (17)190831(10)815061N(30)50 (17)190831(10)815061N(30)200(01)50382903659857 815062N (01)30382903659853 (17)190831(10)815062N(30)50 (17)190831(10)815062N(30)200(01)50382903659857 816499N (01)30382903659853 (17)190831(10)816499N(30)50 (17)190831(10)816499N(30)200(01)50382903659857 821563N (01)30382903659853 (17)191031(10)821563N(30)50 (17)191031(10)821563N(30)200(01)50382903659857 821564N (01)30382903659853 (17)191031(10)821564N(30)50 (17)191031(10)821564N(30)200(01)50382903659857 821565N (01)30382903659853 (17)191031(10)821565N(30)50 (17)191031(10)821565N(30)200(01)50382903659857 821888N (01)30382903659853 (17)191031(10)821888N(30)50 (17)191031(10)821888N(30)200(01)50382903659857 827063N (01)30382903659853 (17)191231(10)827063N(30)50 (17)191231(10)827063N(30)200(01)50382903659857 827064N (01)30382903659853 (17)191231(10)827064N(30)50 (17)191231(10)827064N(30)200(01)50382903659857 827589N (01)30382903659853 (17)191231(10)827589N(30)50 (17)191231(10)827589N(30)200(01)50382903659857 827693N (01)30382903659853 (17)191231(10)827693N(30)50 (17)191231(10)827693N(30)200(01)50382903659857 827699N (01)30382903659853 (17)191231(10)827699N(30)50 (17)191231(10)827699N(30)200(01)50382903659857"

    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