Events

Retiro De Equipo (Recall) de Device Recall Various catheters marketed by Medcomp and AngioDynamics

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
    70472
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1351-2015
  • Fecha de inicio del evento
    2015-02-05
  • Fecha de publicación del evento
    2015-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133853
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    Medcomp has initiated the recall of duo-flow 400xl catheter, hemo-flow catheter, slx catheter, triple lumen infusion catheter, ct rated picc, split cath iii, pc split cath iii because the product shipped was out of specification. one bi (biological indicator) out of 21 on the sterilization load was out of specification.
  • Acción
    On or about 02/03/2015, Medcomp sales representatives notified the affected medical facilities and providing Medcomp's recall letter. This was accomplished by e-mail, telephone, or visit. Distributors for the international accounts were notified by Medcomp via e-mail. A copy of Medcomp's recall letter was attached. For AngioDynamics product- Medcomp notified AngioDynamics by e-mail of the product recall. Every consignee was requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. AngioDynamics was requested to provide an account of the disposition for the total number of product they received.

Device

Device Recall Various catheters marketed by Medcomp and AngioDynamics
  • Modelo / Serial
    Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019; HFS 32/ MGMB440/ 07/14/2017;  HFS24E./MGLY830/07/31/2017; MC061402/MGMD190/07/15/2017;  MC3L-8S/MGMD920/10/16/2019; MR17035211/MGMD680/10/31/2017;  TRAY #593-3/MGMB460/07/15/2017; RMS23602/MBWM930/07/31/2017;  ASPC2816-3/MBWM900/07/31/2017; Tray #55216-3/MBWL780/07/31/2017; ASPC2816-3PC/MBWX290/07/31/2017; 10301207/MGMD930/07/31/2017; 10800701/ MGLY730/ 07/31/2017; 10800702/ MGMD210/ 07/31/2017; 10800703/MGLY740/07/31/2017   AngioDynamics products- model numbers/lot numbers/ expiration dates:  10301207/MGMD930/07/31/2017; 10800701/MGLY730/07/31/2017; 10800702/MGMD210/07/31/2017; 10800703/MGLY740/07/31/2017
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; || AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.
  • 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
  • Empresa matriz del fabricante (2017)
    Medical Components Inc.
  • Source
    USFDA