Events

Rappel de Churchill Medical Systems

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 Vygon Corporation.

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
    58794
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2388-2011
  • Date de mise en oeuvre de l'événement
    2011-04-19
  • Date de publication de l'événement
    2011-06-11
  • 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=100307
  • 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
    Dressing Change Kit - Product Code LKB
  • Cause
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Action
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. 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@vygonus.com.

Device

Churchill Medical Systems
  • Modèle / numéro de série
    Lot Numbers: 10J29, 10J55, 11A18, 11A47 and 11B06.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    United States (FL, MA, MD, and VA).
  • Description du dispositif
    Churchill Medical Systems || AMS-7080CP (Dressing Change Kit). || The device intended use is a dressing change kit.
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation