Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Prismaflex Control Unit

Recall date
April 7, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2066-2020
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Distribution only to Puerto Rico and Guam

Why it was recalled

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

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 Control Unit

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