CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA Ventilator upgrade kits 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
CareFusion 211 Inc dba Carefusion is recalling the AVEA GDE/UIM upgrade kit (12283-PMN). The recall involves 922 units total, with 501 units distributed in the United States and the remainder distributed worldwide in 34 other countries.
The recall was initiated because the AVEA Ventilator Transducer Communication Alarm (TCA) Board contains an incorrect F1 fuse. This fuse may fail or blow, which can cause a loss of power to the User Interface Module (UIM). The AVEA 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 healthcare providers, nor does it report any illnesses or injuries associated with this defect. The recall is classified as Class I by the FDA.
The recalled product
- Product
- AVEA GDE/UIM upgrade kit, 12283-PMN 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
- SevereCareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
FDA (Devices) · 2016-06-22
- SevereCareFusion Recalls AVEA Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- SevereCareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
FDA (Devices) · 2016-06-22
- SevereCareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
FDA (Devices) · 2016-06-22
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