Medical device recalls Moderate risk

Becton Dickinson & Co. recalls Phoenix AST-s Indicator, Catalog Number 246009

Recall date
December 20, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0933-2019
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Arg…

Why it was recalled

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

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

What was recalled

Phoenix AST-s Indicator, Catalog Number 246009

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