BD Alaris Pump Infusion Sets May Deliver Inaccurate Doses
BD Alaris Pump Infusion Sets may operate outside established performance ranges for flow rate, bolus accuracy, and occlusion detection, potentially delivering incorrect medication doses to patients receiving intravenous therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which indicates a serious defect in a medical device that could cause adverse health consequences. Although no reported illnesses or injuries are mentioned in the source text, the classification itself reflects the potentially serious nature of flow rate inaccuracy, dose delivery errors, and occlusion detection failure in an intravenous infusion device.
Plain-English summary
BD Alaris Pump Infusion Sets, manufactured by CareFusion 303, Inc., are medical devices used to deliver intravenous medications and fluids. The recall involves multiple reference numbers and includes all manufacturing lots.
The infusion pump module used with these sets may perform outside the established performance ranges for flow rate accuracy, bolus accuracy, occlusion alarm response time, and post-occlusion bolus volume. This malfunction could result in patients receiving incorrect medication doses during intravenous therapy.
The affected product has been distributed nationwide throughout the United States and internationally to multiple countries including Canada, Australia, United Kingdom, China, France, and others. This is a Class I recall, indicating a serious defect in the medical device that could adversely affect patient health.
The recalled product
- Product
- BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- flow-rate-inaccuracy
- dose-accuracy-error
- occlusion-detection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- All Lots/ UDI: C24101E - 10885403235528
- 10015414 - 10885403233999
- 2447-0007 - 10885403235078
- 24201-0007 - 10885403476341
- 10012645 - 10885403233753
- 2426-0500 - 7613203020992
- 11522558 - 10885403232305
- 2410-0500 - 7613203012492
- 2232-0007 - 10885403463969
- 11613191 - 10885403276026
- 10012144 - 7613203021159
- 10013034 - 10885403232312
- 10013037 - 10885403233784
- 11582773 - 10885403239588
Distribution
Distributed nationwide across the United States.
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