Device recall
Z-1436-2013: Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840…
FDA device recall · Class I · Endologix Inc
Key facts
| Recall number (Z-number) | Z-1436-2013 |
|---|---|
| Recall event | 65248 |
| Product | Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with… |
| Product code | DYB |
| Recalling firm | Endologix Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 19, 2013 |
| 510(k) numbers | K120212 |
| FEI number | 1000125107 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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