Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors
Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.
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 source text explicitly states that the hazard 'may result in serious adverse health consequences,' which aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling 444 units of the Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6), model 35700BAXL. The recall is due to improper documentation of final release testing by service technicians. While the documentation indicated that the full battery of release tests was performed, several specific tests were actually omitted.
The omitted tests include air-in-line detection at 400ml/hr and 800ml/hr, as well as verification of upstream occlusion detection at 800ml/hr. The source text states that improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. The affected units were distributed nationwide in the US and in Puerto Rico.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Baxter Healthcare Corporation for instructions on how to proceed with the recall and replacement or repair of the devices.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 444
Distribution
Part of a larger recall action
This product is one of 5 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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