Events

Rappel de Device Recall Baxter Solution Set with DuoVent Spike

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
    59419
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2920-2011
  • Date de mise en oeuvre de l'événement
    2011-07-21
  • Date de publication de l'événement
    2011-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102723
  • 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
    Intravascular Administration Set - Product Code FPA
  • Cause
    The solution sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. the reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient.
  • Action
    Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Device Recall Baxter Solution Set with DuoVent Spike
  • Modèle / numéro de série
    Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
  • Description du dispositif
    Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. || Baxter Healthcare Corporation. || A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA