Baxter Spectrum IQ Infusion Pump, Product Code 3570009 recallZ-1775-2024 · Baxter Healthcare Corporation · initiated Mar 20, 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
One device was improperly performed testing prior to release from a Service Center.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.
Recall details
- Recall number
- Z-1775-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 20, 2024
- Posted by the FDA
- May 3, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 pump
- Product code
- FRN
- FDA submissions
- K230041
- Distribution
- US Nationwide distribution in the state of Massachusetts.
Product description
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Code information (models, lots, serial numbers)
UDI/DI 00085412610900, Serial Number 3540772
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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