Events

Rappel de Device Recall Umbilicup

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 DeRoyal Industries 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
    61434
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1398-2012
  • Date de mise en oeuvre de l'événement
    2012-01-20
  • Date de publication de l'événement
    2012-04-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108068
  • 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
    Container, empty, for collection & processing of blood & blood components - Product Code KSR
  • Cause
    Device's needle may become dislodged from the cup during shipment or during use.
  • Action
    DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product. If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.

Device

Device Recall Umbilicup
  • Modèle / numéro de série
    Lot Numbers: 17486924, 17920399, 18040342, 18316290, 18551118, 19341884, 19396771, 19464008, 19504031,  19546960, 19743023, 20687057, 21157488, 21413621, 21699341, 22142544, 22373051, 22688811,  23111424, 23161430, 23434063, 23794510, 24095551, 24163955, 24296281, 24451957, 24508634,  24793826, 25043550, 25313548, 25439757, 25747451, 26023059, 26199281, 26544541, 26611133, 26706327, 26943568, 27105291, 27304418, 27571604
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
  • Description du dispositif
    DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Adresse du fabricant
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA