Device recall
Z-1081-2015: VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as…
FDA device recall · Class III · Lacrimedics Inc
Key facts
| Recall number (Z-number) | Z-1081-2015 |
|---|---|
| Recall event | 70036 |
| Product | VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper… |
| Product code | LZU |
| Recalling firm | Lacrimedics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 23, 2015 |
| 510(k) numbers | K140026 |
| FEI number | 2024818 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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