Device product
Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. 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 procedures.
Z-1772-2020
Product summary
- Firm
- Medivators, Inc.
- Event
- Event 84109
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,790 units total
- Official record key
device-enforcement:Z-1772-2020
Official wording
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.
Code information: Lot # / UDI #s: 427416 / 00677964059492208051427416, 427098 / 00677964059492208031427098, 427819 / 00677964059492208071427819, 427154 / 00677964059492208031427154.
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Derived failure modes
-
Unknown
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.