Infusion pump sets recalled over flow rate and occlusion alarm accuracy
CareFusion is recalling BD Alaris Pump Infusion Sets because the pump module used with them may perform outside established ranges for flow rate, bolus accuracy and occlusion alarm timing.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
BD Alaris Pump Infusion Sets are being recalled across reference numbers including C24101E (amber tubing, 15 micron filter, 0.2 micron filter, SmartSite Y-Site), 10015414 (180 micron filter), 2447-0007 (ball valve SmartSite port burette with two SmartSite Y-Sites) and others.
The infusion pump module used with these compatible sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume.
The recall covers all lots. Distribution was nationwide in the United States and internationally to countries including the United Arab Emirates, Australia, Belgium, Bahrain, Botswana, Canada, Switzerland, China and France. The FDA has classified the recall as Class I.
Hospitals using these sets should follow BD's instructions, since the affected parameters govern how much fluid a patient receives and how quickly a blockage is detected.
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.
- Category
- Medical Device — Infusion set
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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