Device recall
Z-0870-2013: MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac…
FDA device recall · Class II · Medrad Inc
Key facts
| Recall number (Z-number) | Z-0870-2013 |
|---|---|
| Recall event | 64329 |
| Product | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients. |
| Product code | DXT |
| Recalling firm | Medrad Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2015 |
| 510(k) numbers | K050456 |
| FEI number | 3006316319 |
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