Device recall
Z-1477-2012: EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable…
FDA device recall · Class II · Ogenix Corporation
Key facts
| Recall number (Z-number) | Z-1477-2012 |
|---|---|
| Recall event | 61635 |
| Product | EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to… |
| Product code | KPJ |
| Recalling firm | Ogenix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2013 |
| 510(k) numbers | K023456 |
| FEI number | 3004036118 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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