Device recall
Z-0217-2015: Edwards Lifesciences Vent Catheters,. Packaged sterile and non-pyrogenic in a…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0217-2015 |
|---|---|
| Recall event | 69565 |
| Product | Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry… |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2016 |
| 510(k) numbers | K113411 |
| FEI number | 1713910 |
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