Events

Retiro De Equipo (Recall) de Device Recall ReSolve Locking Drainage Catheters

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
    71694
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2352-2015
  • Fecha de inicio del evento
    2015-06-29
  • Fecha de publicación del evento
    2015-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138760
  • 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, continuous irrigation - Product Code GBQ
  • Causa
    Merit medical systems, inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the merit resolve drainage catheters and the actual device in the package.
  • Acción
    Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions required of you: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Please work with your Merit Sales Representative to arrange product return. 4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365.

Device

Device Recall ReSolve Locking Drainage Catheters
  • Modelo / Serial
    Lot No: E796578 E796579  MR792035 MR786325  MR797946  MR791206  MR791212 MR786923  E796605 MR786311  MR791660 E796647 RL MR795466  MR786301  E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318  MR786319
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the Virgin Islands.
  • Descripción del producto
    ReSolve Locking Drainage Catheters || The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Dirección del fabricante
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Empresa matriz del fabricante (2017)
    Merit Medical Systems Inc
  • Source
    USFDA