Events

Retiro De Equipo (Recall) de Device Recall PALL Medical Breathing Circuit Filter

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
    68424
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2038-2014
  • Fecha de inicio del evento
    2014-06-04
  • Fecha de publicación del evento
    2014-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127552
  • 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
    Filter, bacterial, breathing-circuit - Product Code CAH
  • Causa
    Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
  • Acción
    Urgent Product Recall Letters (dated 6/03/2014) and Response Forms were sent to customers via fax and e-mail starting on 6/04/14. The letters instruct the direct accounts to examine their inventory and place the affect lots on hold in quarantine. For questions, or if a patient injury associated with this device has been reported to you, please call Karen Peterson directly at 516.801.9267 (office) or 516.644.6171 (cell). The letter for the bulk product also instructs customers to notify their customers of the recall and advise them not use the affected lots if the product had been distributed.

Device

Device Recall PALL Medical Breathing Circuit Filter
  • Modelo / Serial
    REF BB50T: Lots 326902, 402802, 405002;  REF BB50T-BULK: Lots 228702, 229902, 328202
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
  • Descripción del producto
    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. || The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.
  • Manufacturer
    Pall Corporation

Manufacturer

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