Device recall
Z-2092-2017: VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty…
FDA device recall · Class II · Vortran Medical Technology 1, Inc
Key facts
| Recall number (Z-number) | Z-2092-2017 |
|---|---|
| Recall event | 77072 |
| Product | VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support. |
| Product code | BTL |
| Recalling firm | Vortran Medical Technology 1, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2017 |
| 510(k) numbers | K001430, K041473, K973975 |
| FEI number | 1000307109 |
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