Events

Retiro De Equipo (Recall) de Device Recall AR1000 Qoustic Qurette"

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 Arobella Medical, 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
    63808
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0534-2013
  • Fecha de inicio del evento
    2012-11-05
  • Fecha de publicación del evento
    2012-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114801
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • Causa
    This recall has been initiated because the arobella medical 6mm qurette q07 lot numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. the 6 mm qurette is a component of the ar1000 quostic wound therapy system.
  • Acción
    Arobella Medical sent an " Urgent: Medical Device Recall" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.

Device

Device Recall AR1000 Qoustic Qurette"
  • Modelo / Serial
    0001 and 0002
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.
  • Descripción del producto
    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. || Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. || Product Usage: || The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.
  • Manufacturer
    Arobella Medical, LLC

Manufacturer

Arobella Medical, LLC
  • Dirección del fabricante
    Arobella Medical, LLC, 5929 Baker Rd Ste 470, Minnetonka MN 55345-4770
  • Empresa matriz del fabricante (2017)
    Arobella Medical Llc
  • Source
    USFDA