Prismaflex M Set Recall for Mistranslated Weight Restriction Instructions
Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.
- Product
- Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
- Category
- Medical Device
- Distribution
- Distributed nationwide