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 | Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot |
| Product | Automated peritoneal dialysis (APD) cycler |
| Quantity | 10 units |
| Distribution | US Consignee: NY ***Foreign Consignee: Ecuador |
| Initiated | 2016-02-16 |
| Classified | 2016-04-25 |
| Terminated | 2016-12-23 |
| Recall number | Z-1565-2016 |
| 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-1565-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73435/
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