Events

Retiro De Equipo (Recall) de 3M Scotchcast

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
    66052
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2242-2013
  • Fecha de inicio del evento
    2013-08-05
  • Fecha de publicación del evento
    2013-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121377
  • 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
    Bandage, cast - Product Code ITG
  • Causa
    3m is conducting a voluntary product recall of selected lots of 3m" scotchcast" wet or dry cast padding. upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. lack of repellency may result in prolonged cast dry times after exposure to wet conditions. there have been no repo.
  • Acción
    3M sent a Voluntary Product Recall Notification letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to examine their inventory and set aside any affected lots subject to the recall notice. Customers were asked to inform all departments of any affected lots and provide them with a copy of the Notification letter that instructs them to contact their 3M distributor for alternative options. All affected products were to be returned to the 3M distributor they were purchased from. Customers with questions were instructed to contact the 3M Customer Helpline at 1-800-228-3957. For questions regarding this recall call 651-733-1110.

Device

3M Scotchcast
  • Modelo / Serial
    Catalog # - Lot # WDP2 - 792920, 793090, 793640 & 796078. WDP3 - 792921, 793098, 793638, 796077 & 798487. WDP4 - 792922, 793116, 793637, 796079 & 798488. WDP6 792923, 793636, 798489, 799235 & 799236
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO,CT, FL, GA, HI, IL, IN,KS,KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OR,PA, TN, TX, UT,VA, WA, and WI. Internationally to GERMANY, CANADA, BELGIUM, NETHERLANDS, HONG KONG, NEW ZEALAND, AUSTRALIA, INDIA, KOREA, SINGAPORE AND UNITED ARAB EMIRATES, JAPAN, JAMAICA..
  • Descripción del producto
    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. || Intended for use in constructing casts for either wet or dry immobilization.
  • 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