Events

Retiro De Equipo (Recall) de Device Recall Mar Cor Purification Reverse Osmosis System

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 Mar Cor Purification.

¿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
    67516
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1201-2014
  • Fecha de inicio del evento
    2012-06-27
  • Fecha de publicación del evento
    2014-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125653
  • 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
    Water purification system for hemodialysis. - Product Code FIP
  • Causa
    There exists a potential situation with the crimp connection at the pump head assembly. the potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. if this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.
  • Acción
    Mar Cor Technicians started visiting the consignees to make the correction, in June 2012 Mar Cor called the consignee prior to the visit. An Urgent Medical Device correction letter was sent to customers beginning 2/27/2014. the letter identified the affected units, described the issue, stated that a correction has been, or will be made to the devices and asked for a response form be sent back to the firm.

Device

Device Recall Mar Cor Purification Reverse Osmosis System
  • Modelo / Serial
    serial numbers:  1289064, 1289069, 1289159, 1289259, 1289387, 1289650, 1289747, 1289826, 1289949, 1290088, 1290151, 1290333, 1290367, 1290480, 1290489, 1290845, 1290988, 1291042, 1291120, 1291233, 1291373, 1291378, 1291634, 1291777, 1291828, 1291933, 1292031, 1292114, 1292185, 1292185, 1292192, 1292391, 1292546, 1292597, 1292670, 1292674, 1292899, 1292960, 1293010, 1293039, 1293185, 1293190, 1293311, 1293379, 1293414, 1293687, 1293724, 1293771, 1293777, 1293953, 1293957, 1294093, 1294103, 1294171, 1294307, 1294362, 1294433, 1294516, 1294589, 1294727, 1294864, 1294999, 1295113, 1295137, 1295160, 1295186, 1295274, 1295391, 1295514, 1295622, 1295813, 1295871, 1296237, 1296241, 1296246, 1296484, 1296491, 1296582, 1296621, 1296650, 1296695, 1296806, 1297041, 1297046, 1297118, 1297231, 1297234, 1297372, 1297375, 1297394, 1297453, 1297484, 1297610, 1297655, 1297939, 1297943, 1298037, 1298210, 1298266, 1298270, 1298377, 1298407, 1298450, 1298457, 1298575, 1298619, 1298624, 1298704, 1298734, 1298797, 1298820, 1298879, 1298913, 1298952, 1298953, 1299037, 1299120, 1299144, 1299170, 1299241, 1299262, 1299285, 1299331, 1299393, 1299473, 1299512, 1299599, 1299655, 1299656, 1299732.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide. No distribution outside the US.
  • Descripción del producto
    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
  • Manufacturer
    Mar Cor Purification

Manufacturer

Mar Cor Purification
  • Dirección del fabricante
    Mar Cor Purification, 14550 28th Ave N, Minneapolis MN 55447-4817
  • Empresa matriz del fabricante (2017)
    Cantel Medical Corp.
  • Source
    USFDA