FDAFDA · Alimentos y medicamentos·N.º oficial Z-0845-2015
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Publicado el 31 de diciembre de 2014 · Inicio del retiro: 4 de noviembre de 2014
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
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Sterilization Products
- Distribuidor
- Worldwide Distribution.
- Lote
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- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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