Agency classClass IIOur severity:High FDA (Devices)·Z-1663-2018·Announced 2018-05-16

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.

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 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…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: air-in-line
occlusion-detection
Affected units: 444

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 5 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · air in line