Events

Retiro De Equipo (Recall) de Device Recall 3M" SteriVac" Gas Sterilizer/Aerators

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por 3M Company - Health Care Business.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67716
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1318-2014
  • Fecha de inicio del evento
    2014-03-17
  • Fecha de publicación del evento
    2014-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126136
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Sterilizer, ethylene-oxide gas - Product Code FLF
  • Causa
    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.
  • Acción
    3M sent an "Urgent Medical Device Field Correction" letter dated March 6, 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are being notified because our records indicate you received a unit that contains the cartridge puncture assembly that is the subject of this field correction. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3M's goal is to service the affected units with minimal disruption to your facility. Units manufactured outside of the dates November 10, 2006 to December 14, 2007 are not affected. .For Further Information contact 3M Health Care Service Line at 1-800-228-3957 or your local 3M representative.

Device

Device Recall 3M" SteriVac" Gas Sterilizer/Aerators
  • Modelo / Serial
    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 del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Dirección del fabricante
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA