HIGH

CareFusion 303 BD Alaris Infusion Sets Recalled for Flow, Bolus Accuracy Issues (2025)

CareFusion 303 BD Alaris infusion pump modules and compatible infusion sets are recalled nationwide in the U.S. and multiple international markets. The recall covers reference numbers including C24101E and 10015414 and related SmartSite components. The defect may cause flow rate and bolus accuracy deviations, and incorrect occlusion timing. Stop using the device and follow recall instructions from

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brands
CareFusion, BD, BD Alaris...
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

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

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About This Product

BD Alaris infusion pump systems and sets are used in clinical settings to deliver precise medications and fluids. Infusion sets connect to the pump and patient.

Why This Is Dangerous

If the infusion set or module functions outside prescribed ranges, it can lead to incorrect doses or timing, potentially harming patients.

Industry Context

This recall is part of ongoing vigilance for infusion devices and set components; however, no broader pattern is specified.

Real-World Impact

Hospitals and clinics may need to halt use of affected sets, adjust inventory, and coordinate with manufacturers for replacements, affecting workflow and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check if your infusion system is BD Alaris and compare reference numbers to the list.
  2. Review packaging or device documentation for C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 11522558, 2410-0500, 2232-0007, 11613191, 10012144, 10013034, 10013037, 11582773.
  3. Inspect for SmartSite Y-Site components and Ball Valve configurations.

Where to find product info

Official recall notice on FDA enforcement page and manufacturer communications.

What timeline to expect

Notice issued 2025-09-11 with active status; replacements and refunds handled per recall process, typically weeks to months.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or biosafety officer.
  • Contact the manufacturer for written guidance and escalation options.

How to prevent similar issues

  • Vet suppliers and verify reference numbers before use.
  • Implement stock control to segregate affected lots.
  • Engage in routine device verifications and calibration checks.

Documentation advice

Keep copy of recall notice, serials, lot numbers, and all correspondence with suppliers and hospital administration.

Product Details

Brand: CareFusion 303. Product: BD Alaris Pump Infusion Sets and compatible pump infusion sets. Reference numbers include C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 11522558, 2410-0500, 2232-0007, 11613191, 10012144, 10013034, 10013037, 11582773. Distribution: United States nationwide; international sites including United Arab Emirates, Australia, Belgium, Bahrain, Botswana, Canada, Switzerland, China, France, United Kingdom, Gibraltar, Israel, India, Kuwait, Mexico, Malaysia, Netherlands, New Zealand, Philippines, Pakistan, Qatar, Saudi Arabia, Singapore, Taiwan, South_Afr

Reported Incidents

No injury counts are provided in the submission. This section states a Class I recall with high hazard potential but does not list specific incidents or injuries.

Key Facts

  • Class I recall
  • High hazard potential
  • US nationwide distribution; global reach
  • Multiple reference numbers listed
  • Immediate stop-use recommended
  • Recall date 2025-09-11; report date 2025-10-15
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETSINFANTSCHILDRENELDERLYPREGNANTPREGNANT
Injury Types
ELECTRICALBURNELECTRICALFALLELECTRICAL

Product Classification

Product TypeInfusion Pump Accessories (Infusion 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
Recall Status
ACTIVE

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