Events

Retiro De Equipo (Recall) de DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE

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 PEROUSE MEDICAL.

¿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
    77100
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1891-2017
  • Fecha de inicio del evento
    2017-04-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154975
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Causa
    Complaints regarding broken blister.
  • Acción
    Consignees were notified of the recall on April 5, 2017. They were informed of the issue and asked to take the following steps: 1. Inspect your stock to determine if you still have in your ownership devices among which the references and batch codes are listed in front page; 2. Control the potential damage of the blister according to the pictures above and the instructions mentioned on the labeling and the Instruction For Use: any damaged and/or cracked blister must be immediately discarded; 3. Use the compliant products without risk, after control. Indeed, the primary packaging will not deteriorate in time. If, to date, there is no crack in the blister, then the integrity of the product is not compromised; 4- Do not use the non-compliant products; 5. Complete and sign the attached reply form, then return it within 5 working days following the reception of this letter, and keep a copy; 6. Contact customer service for the modalities of return, replacement and associated support at +33 (0)4.72.39.74.13 or by fax at +33 (0}3.44.08.17.67 or by email at iblayon@vvgon.com (CC mhpourriere@vygon.com); 7. Communicate the safety information to any person concerned in your company and to all end customers to which the product were transferred.

Device

DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE
  • Modelo / Serial
    1 5045606 - 15055430 - 15065340 - 15065685 -15065744- 15065858- 15065970- 15075121 - 15075265 - 15075411- 15075821 - 1 5075851 - 15075942 - 15085001 - 15085075 -15085378- 15085435 -15085515- 15085555 -15105052- 15125214- 16015267- 16025034- 16025640
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: AZ (shipped through Belgium to USA), MN, TN
  • Descripción del producto
    DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
  • Manufacturer
    PEROUSE MEDICAL

Manufacturer

PEROUSE MEDICAL
  • Dirección del fabricante
    PEROUSE MEDICAL, ROUTE DU MANOIR, Ivry Le Temple France
  • Empresa matriz del fabricante (2017)
    Perouse Medical
  • Source
    USFDA