Device recall
Z-1420-2013: REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D…
FDA device recall · Class I · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-1420-2013 |
|---|---|
| Recall event | 64631 |
| Product | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG)… |
| Product code | ETN |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 30, 2014 |
| 510(k) numbers | K112686 |
| FEI number | 1045254 |
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