Device recall
Z-0929-03: System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified…
FDA device recall · Class II · System 02 Inc
Key facts
| Recall number (Z-number) | Z-0929-03 |
|---|---|
| Recall event | 26198 |
| Product | System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally… |
| Product code | CAW |
| Recalling firm | System 02 Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2008 |
| 510(k) numbers | K991569 |
| FEI number | 3003038637 |
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