Device recall
Z-0868-2013: Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide…
FDA device recall · Class II · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-0868-2013 |
|---|---|
| Recall event | 64215 |
| Product | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the… |
| Product code | DQY |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2013 |
| 510(k) numbers | K101659 |
| FEI number | 3002827704 |
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