Recall Z-1892-2016— Carefusion 211 Inc dba Carefusion
Class I · Terminated
Class I FDA medical device recall by Carefusion 211 Inc dba Carefusion, initiated 2016-05-17, terminated 2017-09-28. It names 3 FDA 510(k) clearances: K103211, K073069, K013642. 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.. Reason: 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)..
- Recalling firm
- Carefusion 211 Inc dba Carefusion
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-05-17
- Terminated
- 2017-09-28
- Firm location
- Yorba Linda, CA, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.