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
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.
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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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.
If the infusion set or module functions outside prescribed ranges, it can lead to incorrect doses or timing, potentially harming patients.
This recall is part of ongoing vigilance for infusion devices and set components; however, no broader pattern is specified.
Hospitals and clinics may need to halt use of affected sets, adjust inventory, and coordinate with manufacturers for replacements, affecting workflow and patient safety.
Official recall notice on FDA enforcement page and manufacturer communications.
Notice issued 2025-09-11 with active status; replacements and refunds handled per recall process, typically weeks to months.
Keep copy of recall notice, serials, lot numbers, and all correspondence with suppliers and hospital administration.
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
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.
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