Device recall
Z-1967-2012: Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1967-2012 |
|---|---|
| Recall event | 52194 |
| Product | Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| 510(k) numbers | K831759 |
| 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