Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
AVEA GDE/UIM upgrade kit Recalled by Carefusion 211 Inc dba Carefusion Due to CareFusion has identified a potential risk associated with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Carefusion 211 Inc dba Carefusion directly.
Affected Products
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.
Quantity: 922 units total (501 units in US)
Why Was This Recalled?
CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carefusion 211 Inc dba Carefusion
Carefusion 211 Inc dba Carefusion has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report