Events

Rappel de Device Recall Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit

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
    61945
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1805-2012
  • Date de mise en oeuvre de l'événement
    2012-05-11
  • Date de publication de l'événement
    2012-06-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109560
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Cause
    Manufacturer issued a voluntary recall on multiple lots of vy(tm)flush heparin lock flush syringes therefore vygon has subsequently initiated a recall on vygon branded heparin lock flush syringes and kits containing the syringes.
  • Action
    VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.

Device

Device Recall Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
  • Modèle / numéro de série
    Product Code AMS-8522CP-3 - lot 10K50.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  • Description du dispositif
    Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation