Device recall
Z-0136-2013: AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner…
FDA device recall · Class II · Nipro Medical Corporation
Key facts
| Recall number (Z-number) | Z-0136-2013 |
|---|---|
| Recall event | 63302 |
| Product | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. |
| Product code | DQX |
| Recalling firm | Nipro Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2013 |
| 510(k) numbers | K001251 |
| FEI number | 1000132332 |
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