Device recall
Z-2858-2011: Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage…
FDA device recall · Class II · Terumo Medical Corporation
Key facts
| Recall number (Z-number) | Z-2858-2011 |
|---|---|
| Recall event | 59051 |
| Product | Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA) |
| Product code | DQX |
| Recalling firm | Terumo Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2011 |
| 510(k) numbers | K063695 |
| FEI number | 1118880 |
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