Events

Retiro De Equipo (Recall) de Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop

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 Pall 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
    59259
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2856-2011
  • Fecha de inicio del evento
    2011-05-26
  • Fecha de publicación del evento
    2011-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102068
  • 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
    Arterial Line, Cardiopulmonary Bypass, Blood Filter System - Product Code LGB
  • Causa
    Potential for the housing of the arterial line leukocyte reduction filter to separate before or during the priming procedure.
  • Acción
    Pall Medical sent an "Important Customer Notification" letter dated May 26, 2011 to all affected customers. The letter included a description of the problem, affected lots and provided recommendations including the return of the product. For additional information, please contact the firm at (516) 484-0263.

Device

Device Recall Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
  • Modelo / Serial
    Catalog/Model/Reorder Number: LGB Lot # 10-405
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
  • Descripción del producto
    PALL Medical LeukoGuard¿ LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.
  • Manufacturer
    Pall Corporation

Manufacturer

Pall Corporation
  • Dirección del fabricante
    Pall Corporation, 25 Harbor Park Drive, Port Washington NY 11050-4605
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA