Events

Retiro De Equipo (Recall) de Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film

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 Nipro Medical Corporation.

¿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
    79834
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1876-2018
  • Fecha de inicio del evento
    2017-12-19
  • 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=163665
  • 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
    Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
  • Causa
    There is a possibility of the heparin line is occluded.
  • Acción
    Customers were notified on approximately December 19, 2017, via letter. Instructions included to place affected lots on hold and to advise Nipro if any affected product has been further distributed. If affected product has been further distributed, Nipro advised the customer to notify those customers and have the product returned immediately. Additionally Nipro requested that they complete and return the response form to arrange for product return. For further questions, please call (305) 599-7174.

Device

Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is ...
  • Modelo / Serial
    Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : GA, NY, TN, TX.
  • Descripción del producto
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. || The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • Dirección del fabricante
    Nipro Medical Corporation, 3150 NW 107th Ave, Doral FL 33172-2135
  • Empresa matriz del fabricante (2017)
    Nipro Corporation
  • Source
    USFDA