Events

Retiro De Equipo (Recall) de Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter

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 Medical Components, Inc dba MedComp.

¿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
    76625
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1536-2017
  • Fecha de inicio del evento
    2017-02-23
  • Fecha de publicación del evento
    2017-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153698
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The 9.6f port kits were packaged with the incorrect valved peelable introducer. the label states the kit contains a 10f valved peelable introducer. the kit is packaged with a 9f valved peelable introducer. the port lumen will not fit through the introducer during the insertion procedure.
  • Acción
    Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.

Device

Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter
  • Modelo / Serial
    MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution to PR and Panama
  • Descripción del producto
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter || The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • Dirección del fabricante
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • Empresa matriz del fabricante (2017)
    Medical Components Inc.
  • Source
    USFDA