Device recall
Z-1539-2018: WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270…
FDA device recall · Class II · Beaver-Visitec International Inc.
Key facts
| Recall number (Z-number) | Z-1539-2018 |
|---|---|
| Recall event | 79908 |
| Product | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures. |
| Product code | GEI |
| Recalling firm | Beaver-Visitec International Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2019 |
| 510(k) numbers | K911160 |
| FEI number | 1211998 |
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