FDA Device recall Z-0348-2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 by Baxter Healthcare, citing the door on the Spectrum IQ Infusion pump may not be able to fully close.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0348-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-02 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | GA, ID |
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason
The door on the Spectrum IQ Infusion pump may not be able to fully close.
Identifiers
| code_info | 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0348-2025%22
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