Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Prismaflex System, Prismaflex Control Unit

Recall date
February 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1831-2020
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Distribution in US, Puerto Rico

Why it was recalled

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

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

What was recalled

Prismaflex System, Prismaflex Control Unit

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