Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2112-2018·Announced 2018-06-13

Baxter SIGMA Spectrum Infusion Pump Recall for Instructional Mismatch

Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall involving a discrepancy between instructions and supplied equipment (hanger length) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling or documentation issue.

Plain-English summary

Baxter Healthcare Corporation is recalling the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), models 35700BAX and 35700ABB. The recall involves 333,961 units distributed worldwide, including the United States and Canada. The affected units were manufactured between November 1, 2005, and April 22, 2013.

The recall is initiated to update the Instructions for Use (IFU). The current IFU instructs users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets, creating a discrepancy between the instructions and the provided equipment.

Healthcare facilities and users should stop using the affected infusion pumps and contact Baxter Healthcare Corporation for instructions on how to obtain the updated Instructions for Use.

The recalled product

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB 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…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: mis-labeling
Affected units: 333,961

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)

All serial numbers manufactured from 11/1/2005 to 4/22/2013
with release dates 1/1/2005 and forward.

Distribution

Distributed nationwide across the United States.

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.

See all 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · mis labeling