Events

Retiro De Equipo (Recall) de Device Recall Baxter Evacuated Container, 250 mL

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
    55016
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1529-2010
  • Fecha de inicio del evento
    2010-02-15
  • Fecha de publicación del evento
    2010-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89807
  • 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
    Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only - Product Code KPE
  • Causa
    Routine stability testing of the evacuated container product, along with trending of results, indicates that the ph will exceed the upper specification limit prior to the expiration date of this product.
  • Acción
    Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303.

Device

Device Recall Baxter Evacuated Container, 250 mL
  • Modelo / Serial
    Lot numbers: G075531, G076937, and G076794
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia
  • Descripción del producto
    Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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