Events

Retiro De Equipo (Recall) de Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped

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 MOOG Medical Devices Group.

¿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
    72682
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0415-2016
  • Fecha de inicio del evento
    2015-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141973
  • 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
    Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
  • Causa
    Potential for leaking between the purple enfit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
  • Acción
    MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or cdodge@moog.com.

Device

Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Tran...
  • Modelo / Serial
    All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the state of MN.
  • Descripción del producto
    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). || Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Dirección del fabricante
    MOOG Medical Devices Group, 4314 S Zevex Park Ln, Salt Lake City UT 84123-7881
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    USFDA