Events

Rappel de Churchill Medical Systems 22Ga Winged Infusion 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 Churchill Medical Systems, Inc..

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
    61653
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1480-2012
  • Date de mise en oeuvre de l'événement
    2012-04-16
  • Date de publication de l'événement
    2012-05-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Cause
    Mislabeled: mbs-2210 code on case label -22ga winged infusion set, ; however, the product label states 20ga mbs-2010 code listed on device label.
  • Action
    The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com.

Device

Churchill Medical Systems 22Ga Winged Infusion Set
  • Modèle / numéro de série
    Lot Number: 1202077
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada.
  • Description du dispositif
    Churchill Medical Systems Winged Infusion Set, 22Ga, 1", || Latex-Free Winged Infusion Set || Product Code: MBS-2210 || Huber type needle set used for the infusion of medical fluids into implantable ports.
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.