Events

Rappel de Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1

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
    64464
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0914-2013
  • Date de mise en oeuvre de l'événement
    2013-01-21
  • Date de publication de l'événement
    2013-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116188
  • 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
    The label on the device states that the item number is clgy-2210 when the item number on the device label should read clgy-2010. this is a 20ga huber needle set; however, the product label states the pouch contains a 22ga set.
  • Action
    Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.

Device

Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1
  • Modèle / numéro de série
    Lot #1210099
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
  • Description du dispositif
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 || Huber type needle set used for the infusion of medical fluids into implantable ports.
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.