FDA-Device2020-05-27Class II
Prismaflex Control Unit
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-2066-2020More Baxter Healthcare Corporation recalls
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- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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