Events

Retiro De Equipo (Recall) de Device Recall Low Volume Extension Set, 72

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 Smiths Medical Asd 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
    71142
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1730-2015
  • Fecha de inicio del evento
    2015-05-04
  • Fecha de publicación del evento
    2015-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136224
  • 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
    Smiths medical has become aware of an issue with the low volume extension set, (72'' extension set) where under-sized tubing was used in the production of 1 lot of product.
  • Acción
    Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to be aware, including points of use. If these affected Extension Sets have been further distributed to other persons or facilities, please promptly forward the recipients a copy of this Urgent Medical Device Recall Notice.

Device

Device Recall Low Volume Extension Set, 72
  • Modelo / Serial
    Product Reorder Number: 537235C; Lot #2761409
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of KY, MN, NJ, UT, & WI.
  • Descripción del producto
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. || Used to administer fluid and drugs intravenously.
  • Manufacturer
    Smiths Medical Asd Inc

Manufacturer

Smiths Medical Asd Inc
  • Dirección del fabricante
    Smiths Medical Asd Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA