Device recall
Z-1601-05: OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product…
FDA device recall · Class II · Oasis Medical Inc
Key facts
| Recall number (Z-number) | Z-1601-05 |
|---|---|
| Recall event | 33431 |
| Product | OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray and a Tyvek lid is heat-sealed onto the tray. The heat-sealed tray is placed into a polybag. The… |
| Product code | KYG |
| Recalling firm | Oasis Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2014 |
| FEI number | 2083373 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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