Device recall
Z-0801-2020: BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only…
FDA device recall · Class II · Flexicare Medical Ltd.
Key facts
| Recall number (Z-number) | Z-0801-2020 |
|---|---|
| Recall event | 84367 |
| Product | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate… |
| Product code | CCW |
| Recalling firm | Flexicare Medical Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| FEI number | 3006363476 |
At a glance
- None 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