CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4.
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling 922 units of the AVEA Standard ventilator-refurbished (R17311-xx). The recall covers units distributed worldwide, including 501 units in the United States.
The recall is due to a potential risk where an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board may fail or blow. This failure can cause a loss of power to the User Interface Module (UIM). The AVEA Standard ventilator is a continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
The source text does not specify specific actions for consumers or patients. The recall is classified as Class I by the FDA.
The recalled product
- Product
- AVEA Standard ventilator-refurbished, R17311-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
See all →- SevereCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
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- SevereCareFusion Recalls AVEA Ventilators Due to Fuse Defect
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- SevereCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
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