Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

Recall date
March 10, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0101-2022
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
Austria, France, Germany, Great Britain, and Saudi Arabia

Why it was recalled

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

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

What was recalled

smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

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