Device recall
Z-0128-2014: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA device recall · Class III · Helix Medical LLC
Key facts
| Recall number (Z-number) | Z-0128-2014 |
|---|---|
| Recall event | 66423 |
| Product | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 |
| Product code | EWL |
| Recalling firm | Helix Medical LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 21, 2014 |
| 510(k) numbers | K821568 |
| FEI number | 2025182 |
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