Device recall
Z-2253-2015: OxySure Model 615 disposable replacement cartridges, for portable oxygen…
FDA device recall · Class II · Oxysure Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2253-2015 |
|---|---|
| Recall event | 71524 |
| Product | OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. |
| Product code | CAW |
| Recalling firm | Oxysure Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 19, 2020 |
| 510(k) numbers | K052396 |
| FEI number | 3004167951 |
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