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Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement thera
Recalled October 19, 2022 · FDA recall Z-0085-2023 · 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
29,764 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 HF20 Set (product code 109841). 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 →