Device recall
Z-2657-2011: Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube…
FDA device recall · Class II · Arcadia Medical Corporation
Key facts
| Recall number (Z-number) | Z-2657-2011 |
|---|---|
| Recall event | 58828 |
| Product | Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tracheal access for airway management Arcadia Medical Corporation 1450 East American Lane, Schaumburg… |
| Product code | BTO |
| Recalling firm | Arcadia Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2011 |
| 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