FDA Recall

Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

KCER Release Date: March 5, 2025

To: KCER Distribution list- including ESRD Network EDs and QIDs

Affected Product 

The FDA is aware that Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold:

• Sigma Spectrum Infusion System V6 Platform
  
  • Product Code: 35700BAX
  • Unique Device Identifier (UDI): 00085412091570
• Spectrum IQ Infusion System with Dose IQ Safety Software
  
  • Product Code: 3570009
  • Unique Device Identifier (UDI): 00085412610900
• On February 5, 2025, Baxter Healthcare Corporation sent all affected customers a letter recommending the following actions:
  
  • Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump.
  • Contact Baxter at 800-843-7867 to arrange for the return of the affected pumps for inspection and reservicing as applicable.
  • If you received a communication directly from Baxter share Baxter’s communication with departments within your institution who use the affected products.
  • If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal.
• Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

What to Do

Reason for Early Alert

Baxter Healthcare Corporation recalled the Spectrum infusion pumps due to the potential for missing motor mounting screws, which may have occurred during the servicing process.

Baxter is requesting the return of the affected pumps for inspection and reservicing as applicable. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health consequences.

Baxter has reported one serious injury related to this issue.

Device Use

These Baxter Spectrum infusion pumps are intended to be used for the controlled administration of fluids—including medicine, blood, and blood products—to patients.

Contact Information

Customers in the U.S. with questions should contact your Baxter sales representative or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.