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 | 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. |
| Product | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 |
| Quantity | 164,700 units |
| Distribution | nationwide, Canada |
| Initiated | 2017-09-01 |
| Classified | 2017-09-14 |
| Terminated | 2019-08-27 |
| Recall number | Z-3133-2017 |
| 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-3133-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78085/
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