Events

Retiro De Equipo (Recall) de Device Recall Integra Suction Reservoir with AntiReflux Valve

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 Integra LifeSciences Corp..

¿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
    55708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2588-2010
  • Fecha de inicio del evento
    2010-05-07
  • Fecha de publicación del evento
    2010-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91622
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Causa
    The sterility of the product may be compromised. integra lifesciences corp. received a recall notification from saint-gobain performance plastics, france, contract manufacturer of the integra suction reservoir with anti-reflux valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.
  • Acción
    Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form" Integra LIfeSciences can be contacted at 609-936-2495.

Device

Device Recall Integra Suction Reservoir with AntiReflux Valve
  • Modelo / Serial
    Catalog number: 910-500: lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155. Catalog number: 31223; lot numbers 158817, 156484. 157140, 157345, 156618; Catalog number: 31253: lot numbers: 158817, 156484, 157345, 158690, 156618.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka.
  • Descripción del producto
    Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; || Sterile, Rx only. || Manufactured by Integra NeuroSciences Implants S.A., || Sophia Antipolis Cedex, France; || distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; || This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.