Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error
Baxter Healthcare is recalling 9,353 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential software error, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 9,353 units of the SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6). The recall is due to a potential software error that may occur during programming. These devices are intended for the controlled administration of fluids.
The affected devices were distributed worldwide, including in the United States, Canada, Barbados, Jamaica, Bermuda, Guyana, the Bahamas, and Trinidad and Tobago. The specific product code is 35700ABB and the GTIN is 00085412091570.
Healthcare providers and consumers should contact Baxter Healthcare Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 9,353
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 35700ABB
- GTIN 00085412091570
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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