Events

Retiro De Equipo (Recall) de Allegiance Esmark 4" x 108" Bandage, Latex Free, Sterile

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 International Medsurg Connection, 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
    36169
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1527-06
  • Fecha de inicio del evento
    2006-08-16
  • Fecha de publicación del evento
    2006-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48114
  • 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
    Bandage - Product Code MHW
  • Causa
    The bandages labeled as sterile had not been sterilized prior to distribution.
  • Acción
    International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hospitals were requested to contact Cardinal Customer Service at 800-964-5227 to arrange for product return and credit or replacement of all product. All other customers were directed to call 1-888-444-5440 for product return and replacement. All questions were directed to Cardinal Quality Systems at 800-292-9332 or Mr. Manny Gupta at International Medsurg Connection at 847-619-9929.

Device

Allegiance Esmark 4" x 108" Bandage, Latex Free, Sterile
  • Modelo / Serial
    Catalog 24593-043A, lot 06-2071-1
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-043A
  • Manufacturer
    International Medsurg Connection, Inc.

Manufacturer

International Medsurg Connection, Inc.
  • Dirección del fabricante
    International Medsurg Connection, Inc., 935 N Plum Grove Rd Ste F, Schaumburg IL 60173-4770
  • Empresa matriz del fabricante (2017)
    International Medsurg Connection Inc.
  • Source
    USFDA