Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.
Publicado el 18 de julio de 2018 · Inicio del retiro: 23 de mayo de 2018
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
The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Steris Corporation
- Distribuidor
- Worldwide Distribution - US Nationwide in the states of AL, AK, CA, CO, CN, DE, FL, GA, IL, IA, KS, KY, LA, MA, MI, NJ, NY, ND, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WI, and WV. Foreign distribution to Canada.
- Lote
- 3632511020 3634311005 3607312011 3615312001 3611012005 3627012001 3626212001 3633112020 3632612001 3601413013 3629612014 3602113013 3605113001 3615912011 3606613001A 3607413001 3612713001 3614913001 3616213001 3608613001 3623313001 3624113001 3626813001 3627313019 3628113001 3628213002 3629113001 3631613011 3635013015 3601514001 3603614001 3604114024 3604914002 3630113020 3613214010 3611814020 3616714023 3630813004 3628214010 3629414002 3630814002 3631614001 3631414016 3632914001 3632414003 3634914022 3604415042 3605415029 3606115033 3604715027 3608215021 3615215026 3613915001 3619415002 3623015006 3623715001 3627115035 3627315001 3627815020 3629215021 3629515001 3633015001 3632215001 3633615001 3634215001 3632315001 3626415043 3601116014 3602516001 3634315001 3604116001 3604616003 3604716001 3604816001 3606916011 3613716013 3618716001 3600616001 3625616008 3630116001 3632616007 3634216002 3633316017 3635416008 3625716001 3635616001 3603217002 3632116001 3635016001 3604517001 3604617001 3605417001 3606117001 3628616001 3605317001 3605117029 3607417001 3611417015 3612217002 3610917001 3611617001 3613617001 3613717001 3619817008 3619117006 3619917001 3619317001 3617717005 3630317038 3634117001 3601118001 3634517031 3606418014 3606518001 3608718001 3609318016 3610118001 3616814019
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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