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Medivators, Inc. recalls Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 s
Recalled April 29, 2020 · FDA recall Z-1778-2020 · Medivators
Hazard
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. · FDA Class II
Units
53,790 units total
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Description
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.
Product
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - 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.
Manufacturer(s)
Medivators, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →