FDA recall Z-1775-2020

Medivators, Inc. · Class II · device

Product

Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. 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 procedures.

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, England.

Key facts

Status
Terminated
Initiation date
2019-10-09
Report date
2020-04-29
Termination date
2020-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2020