Spectrum IQ Infusion Pump, Product Code 3570009 recallZ-2415-2025 · Baxter Healthcare Corporation · initiated Jul 14, 2025
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
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Customers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST
Recall details
- Recall number
- Z-2415-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2025
- Posted by the FDA
- Aug 22, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 6 units
- Product code
- FRN
- FDA submissions
- K230041
- Distribution
- US distribution to states of: AZ, FL
Product description
Spectrum IQ Infusion Pump, Product Code 3570009
Code information (models, lots, serial numbers)
UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
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.
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