FDA-Device2015-03-11Class II
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Baxter Healthcare Corp.
Hazard
Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
Sold states
US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
Affected count
55 systems
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2015Don't want to check this manually?
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