Events

Retiro De Equipo (Recall) de Medstream 81" (206cm) 20 Universal Administration Set with YSite

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 Medical Specialties Distributors, 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
    62747
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2179-2012
  • Fecha de inicio del evento
    2012-08-03
  • Fecha de publicación del evento
    2012-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111584
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Devices leaking at the y-site.
  • Acción
    Medical Specialties Distributors LLC sent an Urgent Medical Recall letter dated August 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and remove all affected product from use immediately. Further distribution of the affected product should be discontinued immediately. Customers were instructed to contact their customers and inform them of the recall; complete and return the acknowledgement form and fax to 781-344-8320 to arrange for a return and to contact the Customer Service Department at (800) 967-6400 with questions. For questions regarding this recall call 781-344-6000.

Device

Medstream 81" (206cm) 20 Universal Administration Set with YSite
  • Modelo / Serial
    LOT NUMBER: 20111115
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile || Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China || Product Number: MS721 || Disposable Infusion set
  • Manufacturer
    Medical Specialties Distributors, Inc.

Manufacturer

Medical Specialties Distributors, Inc.
  • Dirección del fabricante
    Medical Specialties Distributors, Inc., 800 Technology Center Dr, Stoughton MA 02072-4708
  • Empresa matriz del fabricante (2017)
    Medical Specialties Distributors Inc.
  • Source
    USFDA