Events

Retiro De Equipo (Recall) de Custom Dialysis Kit CF4230 Without Gel

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 Merit Medical Systems, Inc..

¿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
    79426
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1145-2018
  • Fecha de inicio del evento
    2017-09-20
  • 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=162332
  • 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
    Single use instrument tray - Product Code OJV
  • Causa
    1 cuff catheters were incorrectly configured and labeled as 2 cuff product and placed into these dialysis kits.
  • Acción
    On 09/20/17, an URGENT PRODUCT RECALL NOTICE was sent to all direct consignees via mail, informing them of a voluntary recall of specific lots of peritoneal dialysis catheters and catheter containing kits. Consignees were advised to immediately do the following: identify and quarantine effected devices; inform personnel to whom the devices were distributed of the field action; fill out and email the customer response form to response@merit.com within 5 days, and return effected devices within ten days using Federal Express account 112952756. Consignee questions were directed to phone: 801-208-4381 or fax: 801-316-4880. Sales representatives were sent an email communication informing them of the recall and instructing them to contact effected customers to help them return Customer Response Forms and product.

Device

Custom Dialysis Kit CF4230 Without Gel
  • Modelo / Serial
    Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
  • Descripción del producto
    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA