Events

Retiro De Equipo (Recall) de Device Recall Olympus Fluid Aspiration Set

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 Northgate Technologies, 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
    59656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3179-2011
  • Fecha de inicio del evento
    2011-07-25
  • Fecha de publicación del evento
    2011-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103229
  • 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
    Evacuator, gastro-urology - Product Code KQT
  • Causa
    The red tag was assembled to the wrong end of the silicone tubing. the red tag indicates how the fluid aspiration tubing set is loaded into the olympus sp-2 fluid irrigation and aspiration pump.
  • Acción
    The firm, Northgate Technologies, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated August 18, 2011 to the Olympus America customers who ordered the Aspiration Tubing Set, 72-00114-0. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall for subsequent return to Northgate Technologies; if they further distributed this product, they were to identify and notify their customers of the recall, and complete and return the enclosed Return Response Form via fax to (847) 608-9405 or mail to: Northgate Technologies Inc., 1591 Scottsdale Court, Elgin, IL 60123. If you have any questions, please call (224) 856-2222 or e-mail to: ckurek@northgate-tech.com.

Device

Device Recall Olympus Fluid Aspiration Set
  • Modelo / Serial
    catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
  • Descripción del producto
    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 || The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
  • Manufacturer
    Northgate Technologies, Inc.

Manufacturer

Northgate Technologies, Inc.
  • Dirección del fabricante
    Northgate Technologies, Inc., 1591 Scottsdale Court, Elgin IL 60123-9340
  • Empresa matriz del fabricante (2017)
    Trudell Medical Limited
  • Source
    USFDA