BAXTER HEALTHCARE CORPORATION recalls Kaguya Automated Peritoneal Dialysis System
Recalled Product
Kaguya Automated Peritoneal Dialysis System
Hazard / Issue
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
Issued by
FDA
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