Events

Rappel de Device Recall MiniCap with PovidoneIodine Solution

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Baxter Healthcare Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70512
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1269-2015
  • Date de mise en oeuvre de l'événement
    2015-01-22
  • Date de publication de l'événement
    2015-03-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133954
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Cause
    Product may have separating or protruding sponges.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
  • Description du dispositif
    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA