Events

Retiro De Equipo (Recall) de Device Recall Mask adult, oxygen, medium concentration, elastic strap

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 Salter Laboratories, Division of Regulatory Affairs.

¿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
    58454
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0111-2012
  • Fecha de inicio del evento
    2011-03-25
  • Fecha de publicación del evento
    2011-10-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99390
  • 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
    Mask, oxygen - Product Code BYG
  • Causa
    A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
  • Acción
    The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

Device Recall Mask adult, oxygen, medium concentration, elastic strap
  • Modelo / Serial
    Lot 022811; Product code: E8110-7-50
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
  • Descripción del producto
    Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs

Manufacturer

Salter Laboratories, Division of Regulatory Affairs
  • Dirección del fabricante
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA