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 door on the Spectrum IQ Infusion pump may not be able to fully close. |
| Product | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 |
| Quantity | 8 units |
| Distribution | GA, ID |
| Initiated | 2024-10-02 |
| Classified | 2024-11-08 |
| Recall number | Z-0348-2025 |
| 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-0348-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95505/
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