Events

Retiro De Equipo (Recall) de Device Recall Esmark Elastic Bandage

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 Medline Industries 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
    67858
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1649-2014
  • Fecha de inicio del evento
    2014-03-20
  • Fecha de publicación del evento
    2014-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126504
  • 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, elastic - Product Code FQM
  • Causa
    This lot did not go through the correct sterilization procedures. this product may potentially be non-sterile.
  • Acción
    Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.

Device

Device Recall Esmark Elastic Bandage
  • Modelo / Serial
    Product Number: DYNJ05116A .  Lot Number: 13LA1009.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
  • Descripción del producto
    Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA