Medical device recalls Moderate risk

TrypticaseTM Soy Agar with 5% Sheep Blood recalled over Listeria risk

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Becton Dickinson & Co. recalls TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Bl…
Recall number
Z-0196-2018
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan

Why it was recalled

Listeria monocytogenes contamination of non-sterile plated media

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

What was recalled

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.

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