Retiro De Equipo (Recall) de Device Recall HEPFLUSH

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 Fresenius Kabi USA, LLC.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Causa
    The lot failed ph specification.
  • Acción
    Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at /products/pharmaceutical-products/product-updates.html. 2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi. 3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630. Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.


  • Modelo / Serial
    Lot 6005501, Exp. Date 1/2016
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
  • Manufacturer


  • Dirección del fabricante
    Fresenius Kabi USA, LLC, 3 Corporate Dr, Lake Zurich IL 60047-8930
  • Empresa matriz del fabricante (2017)
  • Source