Events

Rappel de Device Recall Churchill Medical

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
    59466
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3049-2011
  • Date de mise en oeuvre de l'événement
    2011-07-15
  • Date de publication de l'événement
    2011-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102841
  • 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
    kit, i.v. start - Product Code LRS
  • Cause
    Outer kit labeled expiration date longer than the expiration of the shortest expired product.
  • Action
    Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com

Device

Device Recall Churchill Medical
  • Modèle / numéro de série
    Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Churchill Medical Latex-Free IV Start Kit || Product Code: AMS-623ATLF || The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label || AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.