Device recall
Z-1328-2014: 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-1328-2014 |
|---|---|
| Recall event | 67819 |
| Product | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No. 410944S; 5/10/12 Weck… |
| Product code | GCJ |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2016 |
| 510(k) numbers | K112456 |
| 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