Device recall
Z-1240-2009: Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD…
FDA device recall · Class II · Edwards Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-1240-2009 |
|---|---|
| Recall event | 51492 |
| Product | Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary… |
| Product code | KRA |
| Recalling firm | Edwards Lifesciences, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2011 |
| 510(k) numbers | K924661 |
| 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