Baxter Healthcare Corporation recalls Prismaflex M Set: M150 (product code 109990). For use in p
Recalled Product
Prismaflex M Set: M150 (product code 109990). 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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