Medical device recalls Moderate risk

Thermo Fisher Scientific (Monterrey) recalls Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen container…

Recall date
April 29, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2126-2020
FDA classification
Class II
Brand / firm
Thermo Fisher Scientific (Monterrey)
Sold / distributed
US Distribution to states of: IL, KY , TX

Why it was recalled

Product was not irradiated; therefore, they are not sterile and do not meet product specification.

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

What was recalled

Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

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