3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
Publicado el 9 de abril de 2014 · Inicio del retiro: 17 de marzo 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
Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- 3M Company - Health Care Business
- Distribuidor
- Worldwide Distribution - USA (nationwide) Distribution including the states of AL, AZ, CA,CO, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, NE, NJ, NY, NC, ND, OH, OK,OA, SC, TX, WA, WV and WI. and the countries of COLOMBIA, VENEZUELA, UAE, THAILAND, GERMANY, CHINA, KOREA, CANADA, JAPAN, RUSSIA, INDIA, POLAND, PERU, AUSTRIA, ISRAEL, INDONESIA, SPAIN, CHILE, MALAYSIA, SWITZERLAND, EL SALVADOR, ECUADOR, LEBANON, MEXICO, ARGENTINA, BULGARIA, TAIWAN, TURKEY,ROMANIA, GUATEMALA and NEW ZEALAND.
- Lote
- Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027 4XL 523122, 522205, 522502, 522287, 522655.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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