Device recall
Z-1747-2014: Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized…
FDA device recall · Class II · NEO METRICS, INC.
Key facts
| Recall number (Z-number) | Z-1747-2014 |
|---|---|
| Recall event | 68279 |
| Product | Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts… |
| Product code | OCY |
| Recalling firm | NEO METRICS, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 16, 2015 |
| 510(k) numbers | K133076 |
| FEI number | 3003631559 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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