Device recall
Z-0032-2016: regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit…
FDA device recall · Class II · Resource Optimization & Innovation Llc
Key facts
| Recall number (Z-number) | Z-0032-2016 |
|---|---|
| Recall event | 71904 |
| Product | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure |
| Product code | FSY |
| Recalling firm | Resource Optimization & Innovation Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2017 |
| FEI number | 3004513970 |
At a glance
- None 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