Events

Retiro De Equipo (Recall) de Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

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 LeMaitre Vascular, 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
    32971
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0219-06
  • Fecha de inicio del evento
    2005-05-17
  • Fecha de publicación del evento
    2005-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41161
  • 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
    Occluder, Catheter Tip - Product Code DQT
  • Causa
    Lemaitre vascular is recalling certain lots of its pruitt aortic occlusion catheters due to a packaging defect which could compromise product sterility.
  • Acción
    The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.

Device

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled...
  • Modelo / Serial
    Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
  • Descripción del producto
    Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Dirección del fabricante
    LeMaitre Vascular, Inc., 3101 37th Ave N, St Petersburg FL 33713-1509
  • Source
    USFDA