Device recall
Z-1778-2020: Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is…
FDA device recall · Class II · Medivators, Inc.
Key facts
| Recall number (Z-number) | Z-1778-2020 |
|---|---|
| Recall event | 84109 |
| Product | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. |
| Product code | FAJ |
| Recalling firm | Medivators, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| 510(k) numbers | K093665 |
| FEI number | 2150060 |
At a glance
- 1–9 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