Events

Retiro De Equipo (Recall) de NEBROS, Roscoe Mini Neb Compressor

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 Compass Health Brands.

¿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
    71112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1720-2015
  • Fecha de inicio del evento
    2015-04-20
  • Fecha de publicación del evento
    2015-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136146
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Causa
    Roscoe medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. these warnings are to better inform end users of proper care when using and storing a roscoe medical nebulizer to reduce user damage (wear & tear) to the power cord.
  • Acción
    Compass Health sent an Urgent Recall Field Correction letters dated April 20, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: ¿ Ensure all affected personnel are fully informed of this notice. ¿ Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. ¿ Advise your customers regarding the proper care and storage of the nebulizers. ¿ Your customers should discard their NEB-ROS User Manual and immediately download the latest versions HERE. ¿ If they are unable to download the most recent version, hard copies can be provided. Please contact Roscoe Medical Customer Support at (800) 376-7263 Monday - Friday 8:00 am EST - 5:00 pm EST. ¿ Complete and return the attached Recall Field Correction Response Form to Roscoe Medical within fifteen (15) days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Roscoe Medical via fax number (440) 572-4261 or via email at corporate@roscoemedical.com.

Device

NEBROS, Roscoe Mini Neb Compressor
  • Modelo / Serial
    Models AG-MNEB and DS-NEB
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution US nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and countries of:: Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Hong Kong, India, Norway, Spain, Trinidad and Tobago & United Kingdom.
  • Descripción del producto
    Roscoe Mini Neb Compressor User Manual for the NEB-ROS || Product Usage: || Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
  • Manufacturer
    Compass Health Brands

Manufacturer

Compass Health Brands
  • Dirección del fabricante
    Compass Health Brands, 21973 Commerce Pkwy, Strongsville OH 44149-5558
  • Empresa matriz del fabricante (2017)
    Compass Health Brands Corp
  • Source
    USFDA