Events

Retiro De Equipo (Recall) de Device Recall Excelsior Medical

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 Excelsior Medical 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
    68573
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2070-2014
  • Fecha de inicio del evento
    2014-06-05
  • Fecha de publicación del evento
    2014-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128242
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Causa
    There is a potential for a leak. a molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
  • Acción
    Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that it was supplied to and notify them at once of the product recall. A phone number was provided in case customers had questions regarding the recall (1.800.487.4276 8:30 am - 5:00 pm EST) as well as an email address (recall12@excelsiormedical.com).

Device

Device Recall Excelsior Medical
  • Modelo / Serial
    Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213  Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Canada.
  • Descripción del producto
    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Dirección del fabricante
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA