Medical device recalls Moderate risk

Becton Dickinson & Co. recalls Enterococcus Screen Agar QUAD Plate

Recall date
June 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0474-2016
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia,…

Why it was recalled

The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

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

What was recalled

Enterococcus Screen Agar QUAD Plate

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