Baxter Healthcare Corporation recalls Prismaflex HF Set: HF1000 (product code 107140), HF1400 (pr
Recalled Product
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
Hazard / Issue
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.
Issued by
FDA
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