Events

Retiro De Equipo (Recall) de Device Recall Medline Angio Drape Pack RadiologyLF

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
    63739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0568-2013
  • Fecha de inicio del evento
    2012-11-08
  • Fecha de publicación del evento
    2012-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114684
  • 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
    General surgery tray (kit) - Product Code LRO
  • Causa
    The non-sterile waste bag component in the custom pack was attached to the outside of the pack in its own packaging. the product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
  • Acción
    The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.

Device

Device Recall Medline Angio Drape Pack RadiologyLF
  • Modelo / Serial
    Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: New York only.
  • Descripción del producto
    Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D || This custom pack includes components necessary for a specific procedure.
  • Manufacturer
    Medline Industries Inc

Manufacturer

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