Events

Rappel de Device Recall Baxter Clearlink System Vented Paclitaxel Set

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
    37362
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0618-2007
  • Date de mise en oeuvre de l'événement
    2007-02-16
  • Date de publication de l'événement
    2007-03-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50416
  • 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
    IV - Product Code FPA
  • Cause
    Baxter has received reports of disconnections/leaks during use of vented paclitaxel administration sets.
  • Action
    Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Clearlink System Vented Paclitaxel Set
  • Modèle / numéro de série
    product code 2C8857: lots R06F05158, R06F22013, R06F22112;
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
  • Description du dispositif
    Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C8857
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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