Medical device recalls Moderate risk

Becton Dickinson & product recalled over Listeria risk

Recall date
June 6, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Becton Dickinson & Co. recalls Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the gr…
Recall number
Z-0976-2015
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.

Why it was recalled

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

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

What was recalled

Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.

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