Carefusion 211 Inc dba Carefusion
FDA Regulatory Profile
Summary
- Total Recalls
- 14 (14 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1898-2016 | Class I | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or ass | May 17, 2016 |
| Z-1894-2016 | Class I | TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum | May 17, 2016 |
| Z-1890-2016 | Class I | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended | May 17, 2016 |
| Z-1889-2016 | Class I | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically | May 17, 2016 |
| Z-1888-2016 | Class I | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechani | May 17, 2016 |
| Z-1892-2016 | Class I | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mec | May 17, 2016 |
| Z-1897-2016 | Class I | Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically con | May 17, 2016 |
| Z-1895-2016 | Class I | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanic | May 17, 2016 |
| Z-1896-2016 | Class I | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assis | May 17, 2016 |
| Z-1891-2016 | Class I | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended | May 17, 2016 |
| Z-1893-2016 | Class I | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator | May 17, 2016 |
| Z-1899-2016 | Class I | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist | May 17, 2016 |
| Z-1609-2015 | Class I | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), int | April 3, 2015 |
| Z-2273-2013 | Class I | Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/2 | September 5, 2013 |