Events

Retiro De Equipo (Recall) de Device Recall Natrelle CUI Tissue Expander

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 Allergan 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
    71498
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2104-2015
  • Fecha de inicio del evento
    2015-06-18
  • Fecha de publicación del evento
    2015-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137978
  • 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
    Expander, skin, inflatable - Product Code LCJ
  • Causa
    Allergan is recalling the natrelle 133 and cui series tissue expanders because the products shipped were beyond the shelf life.
  • Acción
    A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST.

Device

Device Recall Natrelle CUI Tissue Expander
  • Modelo / Serial
    Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    Yes
  • Distribución
    US in the state of Canada
  • Descripción del producto
    Natrelle CUI Series Tissue Expanders. || Product Usage: || Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
  • Manufacturer
    Allergan Inc

Manufacturer

Allergan Inc