Events

Retiro De Equipo (Recall) de Device Recall Negative Pressure Wound Therapy Powered Suction Pump

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 Accuro Medical Product LLC.

¿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
    63064
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0009-2013
  • Fecha de inicio del evento
    2012-08-31
  • Fecha de publicación del evento
    2012-10-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112429
  • 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
    Wound Pro Apex Negative Pressure Wound Therapy - Product Code OMP
  • Causa
    Accuro has received reports of some apex pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
  • Acción
    The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.

Device

Device Recall Negative Pressure Wound Therapy Powered Suction Pump
  • Modelo / Serial
    part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Descripción del producto
    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 || Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
  • Manufacturer
    Accuro Medical Product LLC

Manufacturer

Accuro Medical Product LLC
  • Dirección del fabricante
    Accuro Medical Product LLC, 2854 Hitchcock Ave, Downers Grove IL 60515-4016
  • Empresa matriz del fabricante (2017)
    Accuro Medical Products Llc
  • Source
    USFDA