Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error
Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps 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 any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling 140,006 units of the SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). The recall is being conducted because of a potential software error that may occur during the programming of the device. These pumps are intended to be used for the controlled administration of fluids.
The affected devices were distributed worldwide, including nationwide in the United States and in Canada, Barbados, Jamaica, Bermuda, Guyana, the Bahamas, and Trinidad and Tobago. The specific product code is 35700BAX2 and the GTIN is 00085412498683.
Healthcare facilities and users should contact Baxter Healthcare Corporation for further instructions on how to manage the affected devices.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 140,006
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 35700BAX2
- GTIN 00085412498683
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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