Device recall
Z-0054-2017: Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized…
FDA device recall · Class I · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-0054-2017 |
|---|---|
| Recall event | 75243 |
| Product | Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire… |
| Product code | DQY |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 4, 2018 |
| 510(k) numbers | K060327 |
| 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