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…

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1778-2020

FDA classification

Class II

Brand / firm

Medivators, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.