Device recall
Z-0542-2011: Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147…
FDA device recall · Class II · Edwards Lifesciences Llc
Key facts
| Recall number (Z-number) | Z-0542-2011 |
|---|---|
| Recall event | 57143 |
| Product | Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614 |
| Product code | DTL |
| Recalling firm | Edwards Lifesciences Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2011 |
| 510(k) numbers | K892377 |
| FEI number | 1713910 |
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