Device recall
Z-0957-2014: ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and…
FDA device recall · Class I · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-0957-2014 |
|---|---|
| Recall event | 67266 |
| Product | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. |
| Product code | BTR |
| Recalling firm | Teleflex Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 17, 2016 |
| 510(k) numbers | K091761 |
| FEI number | 3005747797 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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