Device recall
Z-1542-2013: QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1542-2013 |
|---|---|
| Recall event | 65173 |
| Product | QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the… |
| Product code | DWS |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 14, 2014 |
| 510(k) numbers | K981995 |
| 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