Recall Z-1774-2020 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - 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 procedu
| 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 |