Events

Retiro De Equipo (Recall) de Sterile Aquasonic 100 Ultrasound Transmission Gel

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 Parker Laboratories, 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
    79910
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1777-2018
  • Fecha de inicio del evento
    2017-04-13
  • 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=163914
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Causa
    There is a potential for the gel packets to have leaks in the packet seal.
  • Acción
    Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.

Device

Sterile Aquasonic 100 Ultrasound Transmission Gel
  • Modelo / Serial
    Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
  • Descripción del producto
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
  • Manufacturer
    Parker Laboratories, Inc.

Manufacturer

Parker Laboratories, Inc.
  • Dirección del fabricante
    Parker Laboratories, Inc., 286 Eldridge Rd, Fairfield NJ 07004-2509
  • Empresa matriz del fabricante (2017)
    Parker Laboratories Inc
  • Source
    USFDA