Events

Retiro De Equipo (Recall) de Device Recall A M Systems ViroMax viral/bacterial filter

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 A M Systems 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
    55294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0308-2012
  • Fecha de inicio del evento
    2010-03-31
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90493
  • 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
    Filter, bacterial, breathing-circuit - Product Code CAH
  • Causa
    Some viromax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
  • Acción
    A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer. Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession. Please call 360.683.8300, if you have any questions or concerns.

Device

Device Recall A M Systems ViroMax viral/bacterial filter
  • Modelo / Serial
    Lot numbers: 551278, 551311, 551355, 551425, 551432, 551452, 551635, 551658, 551699, 551704, 551727, 551732, 551746, 551800, 551879, 551905, 551954 and 552095.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA ( nationwide) including the states of AZ, CA, FL, KY, MA, MI, NC, OH, OR, and WI., and the countries Canada, Mexico, and Taiwan.
  • Descripción del producto
    ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients || For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
  • Manufacturer
    A M Systems Inc

Manufacturer

A M Systems Inc
  • Dirección del fabricante
    A M Systems Inc, 131 Business Park Loop, P.O. Box 850, Sequim WA 98382-0850
  • Source
    USFDA