Device recall
Z-2069-2015: Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure…
FDA device recall · Class I · Western / Scott Fetzer Company
Key facts
| Recall number (Z-number) | Z-2069-2015 |
|---|---|
| Recall event | 70163 |
| Product | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen. |
| Product code | CAN |
| Recalling firm | Western / Scott Fetzer Company |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 18, 2018 |
| FEI number | 1526809 |
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