Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2113-2018·Announced 2018-06-13

Baxter SIGMA Spectrum Infusion Pump Instructions for Use Update

Baxter Healthcare is updating the Instructions for Use for SIGMA Spectrum Infusion Pumps to correct a discrepancy regarding the height of secondary infusion 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 documentation error (Instructions for Use) that does not describe a direct, immediate physical hazard like fire or shock, but requires correction to ensure proper device usage.

Plain-English summary

Baxter Healthcare Corporation is recalling 122,889 units of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). The recall involves all serial numbers manufactured from July 1, 2014, and forward, with release dates on or after that date. The affected products were distributed nationwide in the United States and in Canada.

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, which do not allow for the 20-inch separation described in the manual.

Healthcare facilities and users should stop using the current Instructions for Use for secondary infusion setup and await the updated documentation from Baxter Healthcare. The firm will be updating the IFU to align the instructions with the physical specifications of the supplied hangers.

The recalled product

Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 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 include…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: mis-labeling
Affected units: 122,889

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 from7/1/2014 and forward
with release dates 7/1/2014 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