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Baxter Healthcare Corporation recalls Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement t
Recalled October 19, 2022 · FDA recall Z-0082-2023 · Baxter Healthcare
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. · FDA Class II
Units
334,932 devices
Sold at
US Nationwide
Description
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.
Product
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →