FDA-Device2022-10-19Class II
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Baxter Healthcare Corporation
Hazard
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Sold states
US Nationwide
Affected count
334,932 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0082-2023Don't want to check this manually?
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