Events

Retiro De Equipo (Recall) de Banicide Advanced

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 Pascal Co 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
    32900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1588-05
  • Fecha de inicio del evento
    2005-08-09
  • Fecha de publicación del evento
    2005-12-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41044
  • 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
    Sterilant, Medical Devices - Product Code MED
  • Causa
    The product, banicide advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
  • Acción
    On August 10, 2005 the firm began notifying consignees via phone and began follow up with notification letters on August 12, 2005. Consignees are being asked to return product. The firm subsequently extended its recall after lots manufactured in June 2005 were tested by FDA and failed the sporicidal testing. The firm identified recipients of the affected product and began to contact them by phone on October 3, 2005. The firm began follow-up notification via mail on October 6, 2005. All customers are requested to respond directly to Pascal regarding disposition of any remaining product.

Device

Banicide Advanced
  • Modelo / Serial
    the following 3 codes were recalled initially: (LOT EXP 110305, LOT EXP 110605, LOT EXP 110705) On October 3, 2005 the firm expanded the recall to include all product produced between October 2004 through August 2005. Following are all the recalled lot codes.  100105, 100205, 100305, 100405, 100505, 100605,  110105, 110205, 110305, 110405, 110505, 110605, 110705,  120105, 120205, 120305,  010106, 010206, 010306, 010406, 010506,  020106, 020206, 020306, 020406, 020506, 020606, 020706, 020806,  030106, 030206, 030306, 030406, 030506, 030606, 030706, 030806, 030906, 031006, 031106,  040106, 040206, 040306,  050106, 050206, 050306, 050406,  060106, 060206, 060306, 060406, 060506,  070106, 070206, 070306, 070406,  080106,
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    To dental product distributors nationwide and to 1 dental product distributor in Israel. Also directly to dental offices nationwide.
  • Descripción del producto
    product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''
  • Manufacturer
    Pascal Co Inc

Manufacturer

Pascal Co Inc
  • Dirección del fabricante
    Pascal Co Inc, 2929 N E Northup Way, P.O. Box 1478, Bellevue WA 98004
  • Source
    USFDA