Baxter Spectrum IQ Infusion System with Dose IQ Safety… recallZ-0348-2025 · Baxter Healthcare Corporation · initiated Oct 2, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The door on the Spectrum IQ Infusion pump may not be able to fully close.
FDA root cause category: Process control
What the company is doing
Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.
Recall details
- Recall number
- Z-0348-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 2, 2024
- Posted by the FDA
- Nov 8, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 8 units
- Product code
- FRN
- FDA submissions
- K230041
- Distribution
- GA, ID
Product description
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Code information (models, lots, serial numbers)
00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page