Device recall
Z-1913-2009: Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single…
FDA device recall · Class II · Edwards Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-1913-2009 |
|---|---|
| Recall event | 52629 |
| Product | Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. |
| Product code | DYB |
| Recalling firm | Edwards Lifesciences, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2012 |
| 510(k) numbers | K981909 |
| FEI number | 2015691 |
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