Class II — Baxter Healthcare Corp.
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. |
| Quantity | 55 systems |
| Distribution | US: Nationwide in the states of (GA, MA, NC, NY, PA, WA) |
| Initiated | 2014-04-03 |
| Classified | 2015-03-04 |
| Terminated | 2017-07-21 |
| Recall number | Z-1245-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-1245-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70194/
Alerts for BAXTER HEALTHCARE CORPORATION
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.