Baxter is recalling certain Spectrum infusion pumps due to the potential for missing motor mounting screws, which could lead to therapy interruptions or delays.

The US Food and Drug Administration (FDA) has issued an early alert regarding Baxter Healthcare Corporation’s recommendation for affected customers to remove certain Spectrum infusion pumps from use or sale.

This alert is part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program. The agency has identified a potentially high-risk device issue and will continue to provide updates as new information becomes available.

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. 

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

Affected Product

  • Sigma Spectrum Infusion System V6 Platform
    • Product Code: 35700BAX
    • Unique Device Identifier (UDI): 00085412091570

Affected Serial Numbers for Spectrum V6

  • Spectrum IQ Infusion System with Dose IQ Safety Software
    • Product Code: 3570009
    • Unique Device Identifier (UDI): 00085412610900

Affected Serial Numbers for Spectrum IQ

What to Do

On Feb 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.

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

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. 

Summary

The FDA has issued an early alert regarding Baxter Healthcare Corporation’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing. This defect could lead to therapy interruptions, delays, or incorrect dosing, posing serious health risks. Baxter has reported one serious injury linked to the issue and is requesting affected customers to stop using the devices and return them for inspection and reservicing. The recall is part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program, and the agency will provide updates as new information emerges.

Key Takeaways

  • FDA Alerts on Baxter Infusion Pump Recall – The FDA has issued an early alert on the recall of Baxter’s Spectrum infusion pumps due to missing motor mounting screws that may compromise therapy delivery.
  • Potential Health Risks Identified – The defect could lead to therapy interruptions, incorrect dosing, or delays, potentially resulting in serious adverse health consequences.

Affected Devices Must Be Returned – Baxter is advising customers to stop using the impacted pumps, locate affected serial numbers, and return the devices for inspection and reservicing.

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