Device recall
Z-2805-2020: PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat…
FDA device recall · Class II · Precision Valve & Automation,Inc
Key facts
| Recall number (Z-number) | Z-2805-2020 |
|---|---|
| Recall event | 86082 |
| Product | PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results… |
| Product code | BTL |
| Recalling firm | Precision Valve & Automation,Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3001151872 |
At a glance
- None 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