This communication is part of the communications pilot to enhance medical device recall programs. The FDA recognizes high-risk potential device issues. The FDA will provide information to the public and update this web page as important new information is now available.
Affected Products
Sigma Spectrum Infusion System Spectrum IQ Infusion System
The FDA acknowledges that Baxter Healthcare Corporation has issued a letter to affected customers who recommend removing certain spectral injection pumps from the location of use or sale.
Sigma Spectrum Infusion System V6 PlatformProduct Code: 35700Baxunique Device Identifier (UDI): 00085412091570
Spectrum IQ Injection System with Dose IQ Safety Software Product Code: 3570009 Unique Device Identifier (UDI): 00085412610900
What to do
On February 5, 2025, Baxter Healthcare Corporation sent a letter to all affected customers recommending the following actions: The product code and serial number are located at the bottom of the infusion pump. We will arrange for 800-843-7867 Contact Baxter to return the affected pump for inspection and reservation, if applicable. Affected products are any product to other facilities, and perform user-level recalls of the affected products distributed to customers and check the relevant boxes in the customer portal. Please update this web page. The FDA is currently reviewing information about this potentially high-risk device issue and will continue to provide information to the public as important new information is now available.
Reasons for early warning
Baxter Healthcare Corporation recalled the spectral injection pump because it could have been missing motor mounting screws that could have occurred during the service process.
Baxter requires returns of affected pumps for inspection and reservations, where applicable. The lack of motor mounting screws can lead to insufficient or excessive treatment, disruption of treatment, or delayed treatment, which can cause serious adverse health effects.
Baxter reports one serious injury related to the issue.
Using the Device
These Baxter spectral infusion pumps are intended for use in the controlled administration of fluids such as drugs, blood, and blood products to patients.
contact address
US customers should contact Baxter Sales representatives or Baxter Global Technical Services Monday through Friday from 7am to 7pm at 800-843-7867.
Unique Device Identifier (UDI)
Unique Device Identifiers (UDIs) help to identify individual medical devices sold in the United States from distribution. UDIs allow for more accurate reporting, reviews, and reviews and analysis of adverse event reports, allowing devices to be identified more quickly, and thus the problem may be resolved more quickly.
How can I report a problem?
Healthcare professionals and consumers may report side effects or quality issues experienced using these devices on a MedWatch. FDA Safety Information and Adverse Event Reporting Program.
Current content content:
03/05/2025
