Device recall
Z-2382-2011: Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The…
FDA device recall · Class II · Newport Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-2382-2011 |
|---|---|
| Recall event | 58629 |
| Product | Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric… |
| Product code | CBK |
| Recalling firm | Newport Medical Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2011 |
| 510(k) numbers | K992133 |
| FEI number | 2023050 |
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