FDAFDA · Alimentos y medicamentos·N.º oficial Z-0616-2014
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Publicado el 8 de enero de 2014 · Inicio del retiro: 21 de noviembre de 2013
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
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Steris Corporation
- Distribuidor
- Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
- Lote
- Model #6500 & 7500
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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