Device recall
Z-1526-06: Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The…
FDA device recall · Class II · Ogenix Corporation
Key facts
| Recall number (Z-number) | Z-1526-06 |
|---|---|
| Recall event | 36130 |
| Product | Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are… |
| Product code | KPJ |
| Recalling firm | Ogenix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2007 |
| 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