FDA recall Z-0059-2020

Product

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

Reason for recall

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.

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

Key facts

Status

Terminated

Initiation date

2019-05-13

Report date

2019-10-16

Termination date

2020-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0059-2020