Events

Retiro De Equipo (Recall) de Intersurgical Breathing Circuit 22mm, nonconductive, single patient use

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
    80250
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2302-2018
  • Fecha de inicio del evento
    2018-04-25
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164961
  • 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
    Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
  • Causa
    When assembling an hme or filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. this could potentially pose a serious health risk to the patient.
  • Acción
    On April 25, 2018, the firm issued an Urgent Medical Device Recall letter to its distributors. Customers were advised of the product issue and recall. Recall Instructions: 1. Immediately discontinue use and quarantine any stock with the product number B0062000 described above in this recall notification. 2. If you have distributed any of this product, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization Number (RGA). Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. 4. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: a. Return the completed form via email to Intersurgical Inc. at Support@intersurgicalinc.com. b. The subject line should contain your Company name and RGA number. i. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. 5. Intersurgical will credit your account when the product is received. If you have any other questions, feel free to contact Intersurgical Customer Support at 1-800-828-9633.

Device

Intersurgical Breathing Circuit 22mm, nonconductive, single patient use
  • Modelo / Serial
    0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributors in IL, NJ, NV, TX, UT.
  • Descripción del producto
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Dirección del fabricante
    Intersurgical Inc, 6757 Kinne St., E. Syracuse NY 13057
  • Empresa matriz del fabricante (2017)
    Intersurgical Incorporated
  • Source
    USFDA