AVEA Comprehensive ventilator-refurbished — Class I medical device recall Z-1891-2016
Terminated recall by Carefusion 211 Inc dba Carefusion, reported 2016-06-22, distributed nationwide. CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on t
| Recall number | Z-1891-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 211 Inc dba Carefusion, Yorba Linda, CA, United States |
| Recall initiated | 2016-05-17 |
| Classified | 2016-06-13 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BO, CA, CL, CN, EC, EG, FR, GB, GT, HU, ID, IE, IN, JP, KW, MX, MY, NI, NL, PH, PL, PY, SA, SG, TH, TR, TW, ZA |
| Reason classes | device malfunction |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1891-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.