Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.
What this means for you
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 35700BAX. The recall covers units distributed nationwide in the United States and Puerto Rico.
The recall was initiated because a service technician improperly documented final release testing. The documentation indicated that the full battery of release tests was performed, but several tests were actually omitted. Specifically, the omitted tests included air-in-line detection at 400 ml/hr and 800 ml/hr, and verification of upstream occlusion detection at 800 ml/hr.
Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. The affected serial numbers are listed in the official recall notice. Users should contact Baxter Healthcare for further instructions on how to address the documentation and testing discrepancies.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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 drugs
- 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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