HIGH

CareFusion 303 Recalls Infusion Pump Sets Due to Performance Issues

CareFusion 303 recalled Alaris Pump Infusion Sets on September 11, 2025, after identifying performance issues. The recall affects multiple model numbers due to potential inaccuracies in flow rate and alarm settings. Healthcare providers must stop using these devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
CareFusion 303
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall includes Alaris Pump Infusion Sets with reference numbers: C24101E, 10015414, 2447-0007, and others. These products were distributed nationwide in the U.S. and internationally to countries including Canada, the UK, and Australia. Specific model numbers include C24101E and 10015414.

The Hazard

The affected infusion pump modules may perform outside established ranges for flow rate and bolus accuracy. This can lead to incorrect medication delivery, posing serious health risks to patients.

Reported Incidents

As of the recall date, no specific incidents or injuries were reported. However, the potential for significant harm exists due to inaccurate medication dosing.

What to Do

Patients and healthcare providers should cease using the recalled infusion sets immediately. Follow the recall instructions provided by the manufacturer and contact CareFusion 303, Inc. for further guidance.

Contact Information

For more information, call CareFusion at 1-800-XXX-XXXX or visit their website at www.carefusion.com.

Key Facts

  • Recall date: September 11, 2025
  • Affected model numbers: C24101E, 10015414
  • No reported injuries or incidents
  • Contact CareFusion for further instructions
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeInfusion Pump Sets
Sold At
Multiple Retailers

Product Details

Model Numbers
C24101E
10015414
2447-0007
24201-0007
10012645
+9 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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