Class II — Baxter Healthcare Corporation
| 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 | Ongoing |
| Reason | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| Product | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. |
| Quantity | 16 units |
| Distribution | US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA. |
| Initiated | 2023-02-22 |
| Classified | 2023-03-30 |
| Recall number | Z-1316-2023 |
| 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 Corporation (Z-1316-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91776/
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