FDA-Device2017-09-20Class II
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Baxter Healthcare Corp
Hazard
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
Sold states
nationwide, Canada
Affected count
164,700 units
Manufactured in
1900 Highway 201 N, N/A, Mountain Home, AR, United States
Products
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3133-2017Don't want to check this manually?
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