Events

Retiro De Equipo (Recall) de Nasal Cannula (Adult) Salter Style

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
    58563
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2237-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99596
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Complaint received that the product in the box was different from labeled product.
  • Acción
    The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 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

Nasal Cannula (Adult) Salter Style
  • Modelo / Serial
    Product Code: 4707-7-7-25, Lot code 012411
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. || Single Patient Use. Do not Sterilize || Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293 || Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
  • 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