Events

Retiro De Equipo (Recall) de Device Recall Alaris Extension Sets with Microbore Tubing

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 CareFusion 303, 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
    80093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2111-2018
  • Fecha de inicio del evento
    2017-11-06
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164545
  • 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
    Reports of incorrect priming volume due to manufacturing with incorrect tubing.
  • Acción
    The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support Center,10020 Pacific Mesa Blvd, San Diego CA 92121, by FAX: 1-858-617-4851 or by EMAIL: SupportCenter@bd.com. Note on the card your distributors name and quantities that will be returned. " Once BD receives the Recall Response Card, the BD Support Center will provide instructions for return of the affected lot numbers and replacement of the affected lots. " " All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods processed through their distributor if the products were purchased through a distributor. " " Your distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the BD Support Center at the number listed below." A second letter was sent on May 2018 adding an additional lot # for Alaris Extension Set with microbore tubing Model number 30914 lot number 17097167 Recall Related Questions BD Support Center Phone: 1-888-562-6018 Hours: 7am to 4pm PST, Monday -Friday Email: SupportCenter@carefusion.com

Device

Device Recall Alaris Extension Sets with Microbore Tubing
  • Modelo / Serial
    Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
  • Descripción del producto
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 || Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Dirección del fabricante
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA