Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036

Recall date
June 12, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2306-2019
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Worldwide Distribution, including US Nationwide

Why it was recalled

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

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 Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036

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