Events

Retiro De Equipo (Recall) de Device Recall MiniCap with PovidoneIodine Solution

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
    70512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1269-2015
  • Fecha de inicio del evento
    2015-01-22
  • Fecha de publicación del evento
    2015-03-13
  • 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=133954
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    Product may have separating or protruding sponges.
  • Acción
    Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. If you received your product directly from Baxter, please complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 1. If you ordered product from a dealer, wholesaler, or distributor/reseller, please follow your supplier's reply and recall process. 2. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 3. Contact Baxter Healthcare Center for Service to arrange for return and credit.Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your ship-to account number ready when calling. 4. Please do not return the Baxter customer reply form to Baxter. Reply forms should be returned to your supplier. For clinical questions, contact Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time. For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.

Device

Device Recall MiniCap with PovidoneIodine Solution
  • Modelo / Serial
    Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
  • Descripción del producto
    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA