Device recall
Z-1712-2009: Twin-Pass Dual Access Catheter, REF 5200, sterilized with Ethylene Oxide, RX…
FDA device recall · Class II · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-1712-2009 |
|---|---|
| Recall event | 52633 |
| Product | Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access… |
| Product code | DQY |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| 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