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BAXTER HEALTHCARE CORPORATION recalls Kaguya Automated Peritoneal Dialysis System
Recalled August 11, 2021 · FDA recall Z-2174-2021 · BAXTER HEALTHCARE
Hazard
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. · FDA Class II
Units
5101 units
Sold at
Worldwide distribution - US Nationwide distribution and the country of Japan.
Description
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.
Product
Kaguya Automated Peritoneal Dialysis System
Manufacturer(s)
BAXTER HEALTHCARE CORPORATION
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →