Events

Retiro De Equipo (Recall) de Device Recall Hudson RCI One Way Valve

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 Telefelx Medical.

¿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
    53960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0652-2010
  • Fecha de inicio del evento
    2009-12-02
  • Fecha de publicación del evento
    2010-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86949
  • 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
    Airway connector (Extension) - Product Code BZA
  • Causa
    Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. each of these valves demonstrate the appropriate direction with a red arrow. the reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665. if the red arrows are not followed, the valve may be placed in the circuit in the wrong.
  • Acción
    Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained. Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990

Device

Device Recall Hudson RCI One Way Valve
  • Modelo / Serial
    Catalog number: 1665, Lot number: 02J0901967
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    CA, IL, NE, NJ, TX, VA, WI and Canada.
  • Descripción del producto
    Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Dirección del fabricante
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA