Device recall
Z-2201-2012: 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that…
FDA device recall · Class II · Nico Corp.
Key facts
| Recall number (Z-number) | Z-2201-2012 |
|---|---|
| Recall event | 62588 |
| Product | 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are… |
| Product code | GZT |
| Recalling firm | Nico Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2012 |
| 510(k) numbers | K120691 |
| FEI number | 3007456622 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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