Spectrum IQ Infusion pump, Product Code 357009 recallZ-1810-2024 · Baxter Healthcare Corporation · initiated Apr 9, 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
There is a potential for cracks on the mount of the front panel of the device.
FDA root cause category: Under Investigation by firm
What the company is doing
Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
Recall details
- Recall number
- Z-1810-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 9, 2024
- Posted by the FDA
- May 13, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9 units
- Product code
- FRN
- FDA submissions
- K230041
- Distribution
- US Nationwide distribution in the states of Ohio, Wisconsin.
Product description
Spectrum IQ Infusion pump, Product Code 357009
Code information (models, lots, serial numbers)
UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419
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