CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
CareFusion 211 Inc dba CareFusion is recalling AVEA Comprehensive ventilators (refurbished, model R17310-xx) due to a potential risk associated with an incorrect F1 fuse on the Transducer Communication Alarm (TCA) Board. The defect may cause the fuse to fail or blow, resulting in a loss of power to the User Interface Module (UIM).
The recall involves 922 units total, with 501 units distributed in the United States. The devices were distributed worldwide, including in Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordan, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
The FDA has classified this recall as Class I. Consumers and healthcare facilities should contact CareFusion for instructions on how to address the defect.
The recalled product
- Product
- AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Carefusion 211 Inc dba Carefusion under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Carefusion 211 Inc dba Carefusion
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- SevereCareFusion Recalls AVEA Ventilators Due to Fuse Defect
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