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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