Events

Retiro De Equipo (Recall) de Device Recall Baxter SelfRighting Luer Lock Tip Cap

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 Baxter Corporation Englewood.

¿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
    69934
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0871-2015
  • Fecha de inicio del evento
    2014-12-04
  • Fecha de publicación del evento
    2014-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131999
  • 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
    Dispenser, liquid medication - Product Code KYX
  • Causa
    Baxter corporation initiated a recall of two lots of self-righting luer lock tip caps because they were distributed prior to closure of the validation.
  • Acción
    Baxter sent an Urgent Product Recall letter via USPS to all affected customers dated December 8, 2014.The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to locate and remove all affected product from their facility, and to contact Baxter Healthcare to arrange for return and credit.Returned products will be destroyed./discarded. If you have questions regarding the content of the communication, please call The Center for One Baxter at (1-800) 422-9837, between the hours of 8:00am and 5:00pm Central time.

Device

Device Recall Baxter SelfRighting Luer Lock Tip Cap
  • Modelo / Serial
    Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
  • Descripción del producto
    Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Dirección del fabricante
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA