Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing
Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.
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: This is a Class II medical device recall involving a critical care product (infusion pump) without reported injuries. The hazard—incomplete post-repair testing—represents a risk-of-harm scenario for a medical device, meeting the Score 3 criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling SIGMA Spectrum Infusion Pump units (Version 6, Product Code 35700BAX). The affected devices were released following repair without complete testing procedures, specifically without flow testing being performed.
Infusion pumps are critical medical devices used to deliver medications and fluids to patients in healthcare settings. If an infusion pump has not been properly tested after repair, there is a potential risk that the pump may not operate correctly, which could affect the safe and accurate delivery of medications.
Healthcare facilities and users who may be affected should contact Baxter Healthcare Corporation for information about this recall and instructions on how to proceed.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 1
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)
- GTIN 00085412091570
- Serial Number: 779515
Distribution
Part of a larger recall action
This product is one of 2 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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