Device recall
Z-0399-2021: Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0399-2021 |
|---|---|
| Recall event | 86642 |
| Product | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications. |
| Product code | DQX |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 2, 2021 |
| FEI number | 1820334 |
At a glance
- None 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