Events

Retiro De Equipo (Recall) de Device Recall Plastic Dignity Low Profile CT Port

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
    78221
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0533-2018
  • Fecha de inicio del evento
    2017-05-25
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158909
  • 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 kit was packaged with the incorrect introducer needle size. the label indicates the kit contains an 18g needle w/echo tip. the kits were packaged with a 21g needle w/echo tip.
  • Acción
    On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201.

Device

Device Recall Plastic Dignity Low Profile CT Port
  • Modelo / Serial
    Lot # MHGB030 Exp. Date 2020-07-30
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Arabia, Australia, Israel, Brunei & Jamaica
  • Descripción del producto
    6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 || Product Usage: || 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