Events

Rappel de Device Recall Vygon

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 MFG, Inc., dba/ 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
    75816
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0787-2017
  • Date de mise en oeuvre de l'événement
    2016-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151374
  • 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
    Incorrect priming volume is printed on the device package.
  • Action
    Vygon sent an Urgent Medical Device Recall letter dated November 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2. Count and document your affected inventory on the "Recall Acknowledgement and Inventory Return Form; 3. Fax or email the form to Vygon including customer contact information; 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up; 6. All inventory will be credited or replaced at no cost to you. For questions contact local sales representative or Vygon's Customer Service Department at 1-800-473-5414.or by email at customerservice@vygonus.com.

Device

Device Recall Vygon
  • Modèle / numéro de série
    1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution in the state of CA
  • Description du dispositif
    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 || Product Usage: || Accessory devices used to administer medical fluids.
  • Manufacturer
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
  • Adresse du fabricant
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., 87 Venture Dr, Dover NH 03820-5914
  • Société-mère du fabricant (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA