Device recall
Z-1777-2020: Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI…
FDA device recall · Class II · Medivators, Inc.
Key facts
| Recall number (Z-number) | Z-1777-2020 |
|---|---|
| Recall event | 84109 |
| Product | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190… |
| 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