Recall Z-1777-2020 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Medivators, Inc.
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 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or
| Date | Oct 9, 2019 |
| Status | Terminated |
| Reason | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. |
| Root cause | Equipment maintenance |
| Action | An Urgent Medical Device Recall Notification letter was sent to customers via certified mail next day delivery on 10/09/2019. The letter identified affected product, stated reason for recall, asked for product to be quarantined and discontinue use. Customers are to return product to Medivators by obtaining a Return Material Authorization from Customer Service. A response form was asked to be returned. Questions can be directed to Customer Service at 1-800-444-4729. |
| Quantity | 53,790 units total |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093665 | ENDO SMARTCAP Byrne Medical, Inc., Dec 15, 2009 |