Events

Retiro De Equipo (Recall) de Device Recall 3M AttestTM Autoreader

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
    68415
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2002-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127541
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Causa
    Labeling on units shipped prior to may 16th, 2014 did not contain the statement "this product contains dry natural rubber" as required by the united states food and drug administration (fda) for medical devices. the non-slip pads at the bottom of the unit contain dry natural rubber. one incident of an allergic reaction in a sensitized individual has been reported.
  • Acción
    Consignees were sent on 6/9/2014 a 3M "Urgent Medical Devices Correction" letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.

Device

Device Recall 3M AttestTM Autoreader
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
  • Descripción del producto
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. || These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
  • 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