Medical device recalls Moderate risk

Life Technologies Corporation recalls CTSTM Essential 8 Medium

Recall date
June 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0275-2020
FDA classification
Class II
Brand / firm
Life Technologies Corporation
Sold / distributed
StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI. StemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil, Canada, Chile, Chi…

Why it was recalled

Component was not tested by the supplier for adventitious agents

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

What was recalled

CTSTM Essential 8 Medium

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