Retiro De Equipo (Recall) de Arthroscopy Outflow/Suction Tubing

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 Linvatec Corp. dba ConMed Linvatec.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Catheter, infusion - Product Code JCY
  • Causa
    On 09/13/2010 conmed linvatec, largo, fl initiated a recall on 24k100 arthroscopy outflow/suction tube set used with the conmed linvatec 24k pump. the 24k100 arthroscopy outflow/suction tubing set lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
  • Acción
    Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit. Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office. If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701. If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.


  • Modelo / Serial
    Lot:  22747-000, 22748-000, 22749-000.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain.
  • Descripción del producto
    ***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900*** || For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
  • Manufacturer


  • Dirección del fabricante
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Empresa matriz del fabricante (2017)
  • Source