Device recall
Z-0338-2007: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP)…
FDA device recall · Class II · Edwards Lifesciences Technology SARL
Key facts
| Recall number (Z-number) | Z-0338-2007 |
|---|---|
| Recall event | 36934 |
| Product | Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 |
| Product code | DYG |
| Recalling firm | Edwards Lifesciences Technology SARL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2012 |
| 510(k) numbers | K812563 |
| FEI number | 2648045 |
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