Events

Retiro De Equipo (Recall) de Vacuum Collection Bottle

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 Ohio Medical Corporation.

¿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
    53192
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0090-2010
  • Fecha de inicio del evento
    2009-09-21
  • Fecha de publicación del evento
    2009-10-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84897
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Causa
    The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. the recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
  • Acción
    Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.

Device

Vacuum Collection Bottle
  • Modelo / Serial
    The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: || 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; || 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

Ohio Medical Corporation
  • Dirección del fabricante
    Ohio Medical Corporation, 1111 Lakeside Dr, Gurnee IL 60031
  • Source
    USFDA