Events

Retiro De Equipo (Recall) de STAT 2 Pumpette

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 ConMed 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
    60703
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0685-2012
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106380
  • 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, administration, intravascular - Product Code FPA
  • Causa
    Conmed received 16 complaints for stat 2 pumpette¿ devices for inaccurate flow rates and for leakage from the body of the compensating controller. the investigation of the complaints determined that the stat 2 pumpette¿ compensating controller on several complaint samples had been assembled incorrectly.
  • Acción
    ConMed sent an "Urgent Medical Device Recall" letters and Reply Forms dated April 15, 2011 to the domestic consignees via UPS Priority Mail pouches and to the foreign consignees via FedEx International Priority. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to review their inventory and immediately stop use of the affected devices and return them to ConMed Corporation. Consignees who had distributed the affected products outside of their facility were instructed to immediately notify their customers of the recall and provide them with a copy of this notice. Consignees were asked to complete and return the enclosed Reply Form. For questions call 315-624-3237 or email ivcontroller@conmed.com

Device

STAT 2 Pumpette
  • Modelo / Serial
    Beginning Lot Code 0603241, Ending Lot Code 1103114
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) - including the countries of: Australia, Barbados, Belgium, Bermuda, Canada, Egypt, Israel, India, Italy, Korea, New Zealand, Philippines and Saudi Arabia.
  • Descripción del producto
    STAT 2 Pumpette¿ Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. || Product Usage: || The STAT 2 Pumpette¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. || The STAT 2 Pumpette¿ Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. || This is a disposable device with a sterile, nonpyrogenic fluid path.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Dirección del fabricante
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA