Device recall
Z-0768-2013: Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400…
FDA device recall · Class II · Oxus America, Inc.
Key facts
| Recall number (Z-number) | Z-0768-2013 |
|---|---|
| Recall event | 64057 |
| Product | Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases. |
| Product code | CAW |
| Recalling firm | Oxus America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2013 |
| 510(k) numbers | K020324 |
| FEI number | 3008841036 |
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