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Recall Observatory FDA recall evidence

Device product

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

Z-0060-2020

May 13, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82851
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0060-2020

Official wording

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 information: 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 pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.