Device recall
Z-0135-2008: THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra…
FDA device recall · Class II · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-0135-2008 |
|---|---|
| Recall event | 44879 |
| Product | THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label) |
| Product code | DQX |
| Recalling firm | Cook, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2008 |
| 510(k) numbers | K832178 |
| FEI number | 1820334 |
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