Events

Rappel de Device Recall CENTURION Port Access Tray

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 Centurion Medical Products 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
    58346
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2325-2011
  • Date de mise en oeuvre de l'événement
    2011-03-31
  • Date de publication de l'événement
    2011-05-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99105
  • 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 MCY
  • Cause
    This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
  • Action
    Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

Device

Device Recall CENTURION Port Access Tray
  • Modèle / numéro de série
    BATCHES 2009100950, 2009103050, 2009120750, 2009122850, 2010060350, 2010062250, 2010070950, 2010081850, 2010082450 AND 2010082650.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Material DT12050, PORT ACCESS TRAY, CENTURION Port Access Tray, Reorder DT 12050, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895 || USA 800.248.4058 www.centurionmp.com || FACILITATES LINE INSERTION || DT12050 PORT ACCESS TRAY
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Adresse du fabricant
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA