Device recall
Z-1286-2014: 5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm)…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1286-2014 |
|---|---|
| Recall event | 67710 |
| Product | 5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. |
| Product code | GCJ |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2017 |
| 510(k) numbers | K112456 |
| 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