Device recall
Z-0279-2009: Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0279-2009 |
|---|---|
| Recall event | 49392 |
| Product | Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The cannula is a nitinol needle that is used to re-enter the true lumen of the vessel. |
| Product code | MCW |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2008 |
| 510(k) numbers | K001577, K014117, K032298, K040771, K043534 |
| FEI number | 1016427 |
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