Device recall
Z-1596-2015: ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a…
FDA device recall · Class III · Arc Medical Inc
Key facts
| Recall number (Z-number) | Z-1596-2015 |
|---|---|
| Recall event | 70662 |
| Product | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit. |
| Product code | BYD |
| Recalling firm | Arc Medical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 29, 2017 |
| 510(k) numbers | K903054 |
| FEI number | 1000111925 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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