Baxter Spectrum IQ Infusion System Recalled for Potential Software Error
Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential software error without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System with Dose IQ Safety Software. The recall involves 112,463 devices intended for the controlled administration of fluids.
The recall was initiated because there is a potential software error during programming. The devices were distributed worldwide, including the United States, Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Healthcare providers and consumers should stop using the affected devices and contact Baxter Healthcare Corporation for further instructions. The product code is 3570009 and the GTIN is 00085412610900.
The recalled product
- Product
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 112,463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code 3570009
- GTIN 00085412610900
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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