Events

Rappel de Baxter Interlink System Buretrol Solution Set with 150 mL Burette NonDEHP

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
    63059
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0013-2013
  • Date de mise en oeuvre de l'événement
    2012-09-07
  • Date de publication de l'événement
    2012-10-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112401
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Baxter has determined that the ball-valve feature of the buretrol solution sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
  • Action
    Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.

Device

Baxter Interlink System Buretrol Solution Set with 150 mL Burette NonDEHP
  • Modèle / numéro de série
    product code 2H7519, all lots
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
  • Description du dispositif
    Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; || Product Usage: The device is used for 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.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA