Agency classClass IIOur severity:High FDA (Devices)·Z-1665-2018·Announced 2018-05-16

Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors

Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.

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 risk-of-harm product where the source text states that improper detection 'may result in serious adverse health consequences,' but no specific injuries or illnesses are reported in the text.

Plain-English summary

Baxter Healthcare Corporation is recalling 444 units of the Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6), model 35700BAXR. The recall was initiated because service technicians improperly documented final release testing on the products. The documentation indicated that the full battery of release tests was performed, but in reality, several specific tests were 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 notes 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 recall notice. The specific serial numbers affected are: 745365, 750241, 750330, 752814, 754975, 757930, 762405, 763117, 764490, 768855, 772652, 773031, 773134, 773520, 774413, 778845, 779430, 779822, 781545, 782706, 782985, 783185, 787001, 793146, 833195, 865842, 883498, 883854, 889556, 889775, 890230, 891398, 891421, 891647, 891689, 901881, 917897, 917963, 919594, 919736, 919837, 921078, 921819, 924734, 928406, 937123, 940345, 940860, 940949, 941786, 944619, 966019, 990542, 996435, 996823, 997156, 998126, 1011229, 1011544, 1014955, and 1027799.

The recalled product

Product: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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
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

See all →

Moderate
Baxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
Moderate
Baxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Moderate
Baxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Severe
Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16

Same hazard · air in line