FDAFDA · Alimentos y medicamentos·N.º oficial Z-0830-2021
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
Publicado el 20 de enero de 2021 · Inicio del retiro: 19 de noviembre 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
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Steris Corporation
- Distribuidor
- Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark, Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Canada, China, Germany, Japan, Norway, Poland, Qatar, Romania, Sweden, Thailand.
- Lote
- Model# M20350 Lot# 1811273,1811277,1906484,1908593,1909635,1910651, 1911658,2001730,2004770 Model# M20358 Lot# 1903408,1906508,1907556,1909644,2001718,2004772 Model# M20359 Lot# 1811278,1906499,1910649,1911680,1911691,1912708, 2001719,2004768 Model# M20400 Lot# 1901340,1901349,1902374,1904448,1904464,1905505, 1906529,1907571,1908595,1909624,1910653,1912700, 2001717,2004766,2004774,2006797
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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