CareFusion Recalls Alaris Infusion Pump Administration Sets Due to Priming Issues
CareFusion 303, Inc. is recalling Alaris Infusion Pump administration sets because users reported being unable to prime the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling specific Alaris Infusion Pump administration sets, including Infusion Sets, VersaSafe Infusion Sets, and SmartSite Infusion Sets. The recall covers 118,254,342 units distributed worldwide, including the United States, Canada, Australia, New Zealand, the EU, and other international locations.
The recall was initiated due to complaints where users were unable to prime the administration set. These sets are used for the intravenous administration of fluids, medications, nutritional support, and transfusion therapy. The affected products were manufactured between January 2017 and March 2018.
Healthcare facilities and users should stop using the affected administration sets and contact CareFusion 303, Inc. for further instructions on the recall process.
The recalled product
- Product
- Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and…
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pumps
- Hazard
- Affected units
- 118,254,342
Distribution
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