FDA-Device2020-05-27Class II
Prismaflex Control Unit
Baxter Healthcare Corporation
Hazard
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Sold states
Distribution only to Puerto Rico and Guam
Affected count
5 devices US territories
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Prismaflex Control Unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2020Don't want to check this manually?
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