Events

Retiro De Equipo (Recall) de Baxter Interlink System Buretrol Solution Set

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 Healthcare Corp..

¿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
    56699
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0070-2011
  • Fecha de inicio del evento
    2010-09-03
  • Fecha de publicación del evento
    2010-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94308
  • 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
    There are leaks in the drip chamber check valve subassembly of the solution set. a leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.
  • Acción
    Baxter sent an "Urgent Product Recall" letter dated September 2, 2010, via first class mail to the direct account, to the attention of the Director of Materials Management, with a copy sent to the Director of Nursing, on the same date, informing them that leaks were detected in the Drip Chamber Check Valve Subassembly used in the affected lot of Interlink System Buretrol Solution Sets. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection. The account was requested to examine their inventory in all locations to determine if they have any of the affected lot and remove the affected product from inventory; call Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Baxter Interlink System Buretrol Solution Set
  • Modelo / Serial
    product code 3C0166, lot GR288365
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: Wisconsin only.
  • Descripción del producto
    Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38" (97 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, 60 DPM; a sterile Rx IV fluid pathway device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0166 || The administration of fluids from a container into the patient's vascular system through a vascular access device
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA