Events

Retiro De Equipo (Recall) de Device Recall 3M Comply EO Chemical Indicators Strips

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 / Medical Division.

¿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
    46950
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1568-2008
  • Fecha de inicio del evento
    2008-03-19
  • Fecha de publicación del evento
    2008-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68615
  • 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
    Physical/Chemical Sterilization Process Indicator - Product Code JOJ
  • Causa
    A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.
  • Acción
    Customers and Distributors were each sent a "Voluntary Product Recall" letter dated 3/17/08 on 3/19/08. The letter states that use of the affected product should immediately be discontinued, stocks should be checked for any remaining inventory, and reprocess any unused packs using the product not from the affected lot or from an alternative supplier. The letter requested consignees to notify 3M whether the facility has affected product or not by sending the "Product Return Form". Replacements will be provided to those with affected products remaining in their stock.

Device

Device Recall 3M Comply EO Chemical Indicators Strips
  • Modelo / Serial
    2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA,  2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB, 2009-04AA, 2009-05AA,  2009-08AA, 2009-09AA.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, CT,DC, DE, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS,MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
  • Descripción del producto
    3M Comply EO Chemical Indicators Strips, Catalog #1251 || The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. || 3M Health Care || 3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Dirección del fabricante
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, South St Paul MN 55144
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA