Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy Recalled by Baxter Healthcare Corp. Due to Additional warning in the AMIA APD System labeling...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corp. directly.
Affected Products
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Quantity: 55 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corp.
Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report