FDA-Device2022-10-19Class II
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). 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
524,376 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2023Don't want to check this manually?
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