FDAFDA · Food and drugs·Recall number Z-1774-2020
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. 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.
Published April 29, 2020 · Recall initiated: October 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medivators, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
- Lot
- Lot # / UDI #s: 426407 / 006779640590942207241426407, 427516 / 006779640590942208051427516, 428107 / 006779640590942208081428107, 427865 / 006779640590942208071427865.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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