Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

Recall date
May 13, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0054-2020
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

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