Device recall
Z-1506-2014: Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1506-2014 |
|---|---|
| Recall event | 67648 |
| Product | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. |
| Product code | KNT |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2016 |
| 510(k) numbers | K981203 |
| FEI number | 3005747797 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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