Baxter Healthcare Corporation recalls Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Recalled December 20, 2023 · FDA recall Z-0550-2024 · Baxter Healthcare

Hazard

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. · FDA Class II

Units

339,936 devices

Sold at

Worldwide distribution - US Nationwide and the country of Canada.

Description

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Product

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Manufacturer(s)

Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →