Device recall
Z-1385-2019: enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-1385-2019 |
|---|---|
| Recall event | 82393 |
| Product | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. |
| Product code | LGZ |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 22, 2020 |
| 510(k) numbers | K060537 |
| FEI number | 2050001 |
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