Medivators, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1773-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. 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.
Class II
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.
Lot # / UDI #s: 426399 / 006779640594692207241426399, 426401 / 006779640594692207241426401.
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Voluntary: Firm initiated