Device recall
Z-0804-2016: Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia…
FDA device recall · Class I · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0804-2016 |
|---|---|
| Recall event | 73137 |
| Product | Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended… |
| Product code | BSZ |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 6, 2016 |
| 510(k) numbers | K133958 |
| FEI number | 3008355164 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database