FDAFDA · Alimentos y medicamentos·N.º oficial Z-1390-2020
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Publicado el 4 de marzo de 2020 · Inicio del retiro: 16 de enero de 2020
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
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Maquet Cardiovascular Us Sales, Llc
- Distribuidor
- U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
- Lote
- Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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