Events

Retiro De Equipo (Recall) de Device Recall Airway balloon catheter

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 Acclarent, 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
    61070
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1095-2012
  • Fecha de inicio del evento
    2012-01-30
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107235
  • 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
    Bronchoscope accessory - Product Code KTI
  • Causa
    Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
  • Acción
    Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales Representative.

Device

Device Recall Airway balloon catheter
  • Modelo / Serial
    Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia
  • Descripción del producto
    Inspira AIR Balloon Dilation System, || size 18 x 40; || Manufactured by Acclarent, Inc. || 1525-G O'Brien Drive, Menlo Park, CA 94025 || Product Usage: Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.

Manufacturer

Acclarent, Inc.
  • Dirección del fabricante
    Acclarent, Inc., 1525b Obrien Dr, Menlo Park CA 94025-1463
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA