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.
What this means for you
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
- 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.
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