Device recall
Z-1821-2014: HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating…
FDA device recall · Class I · Nitinol Devices and Components, Inc.
Key facts
| Recall number (Z-number) | Z-1821-2014 |
|---|---|
| Recall event | 68419 |
| Product | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates… |
| Product code | DQX |
| Recalling firm | Nitinol Devices and Components, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 13, 2015 |
| 510(k) numbers | K121398 |
| FEI number | 3007635982 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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