Device recall
Z-1628-2012: Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck…
FDA device recall · Class II · Arcadia Medical Corporation
Key facts
| Recall number (Z-number) | Z-1628-2012 |
|---|---|
| Recall event | 61663 |
| Product | Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management. |
| Product code | BTO |
| Recalling firm | Arcadia Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2012 |
| 510(k) numbers | K031553 |
| FEI number | 3004590970 |
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