FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 29 de abril de 2020 · Inicio del retiro: 9 de octubre de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medivators, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
- Lote
- Lot # / UDI #s: 426407 / 006779640590942207241426407, 427516 / 006779640590942208051427516, 428107 / 006779640590942208081428107, 427865 / 006779640590942208071427865.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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