FDA-Device2023-12-20Class II
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Baxter Healthcare Corporation
Hazard
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
339,936 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2024Don't want to check this manually?
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