Events

Retiro De Equipo (Recall) de Device Recall IS Can Disposable CO2 absorber

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 Intersurgical 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
    60381
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0518-2012
  • Fecha de inicio del evento
    2011-02-09
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105216
  • 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
    Absorber, carbon-dioxide - Product Code BSF
  • Causa
    Intersurgical incorporated has issued a voluntary recall of the is cans carbon dioxide absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
  • Acción
    Intersurgical Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 8, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected product found. A Recall Response Form was attached to the letter for customers to complete and return via fax at 315-451-3696, Attn: Customer Service. Contact Customer Service at 1-800-828-9633 if you have questions concerning this recall.

Device

Device Recall IS Can Disposable CO2 absorber
  • Modelo / Serial
    Product 2194: Lot numbers 1101240 (exp. date 2013-04), 1101425 (exp. date 2013-05), 1101426 (exp. date 2013-05), 1101902 (exp. date 2013-06); Product 2195: Lot numbers 1102927 (exp. date 2013-08), 1102596 (exp. date 2013-07), 1101423 (exp. date 2013-05), 1102596 (exp. date 2013-07); Product 2196: Lot numbers 1100392 (exp. date 2013-02), 1101241 (exp. date 2013-04), 1101426 (exp. date 2013-05), 1103379 (exp. date 2016-01); Product 2197: Lot numbers 1101281 (exp. date 2013-05), 1102597 (exp. date 2013-08); Product 2198: Lot numbers 1101107 (exp. date 2013-04), 1101427 (exp. date 2013-05), 1101428 (exp. date 2013-05).
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.
  • Descripción del producto
    The IS Can Disposable CO2 absorber x 6 --- || Carbon Dioxide absorbent for use on GE rebreathing systems --- || Manufactured in the United Kingdom for: Intersurgical Incorporated --- || 417 Electronics Parkway, Liverpool, NY 13088. || Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Dirección del fabricante
    Intersurgical Inc, 417 Electronics Pkwy, Liverpool NY 13088
  • Source
    USFDA