Events

Rappel de BD Vacutainer Push Button collection Set

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 Becton Dickinson & Company.

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
    56972
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0816-2011
  • Date de mise en oeuvre de l'événement
    2010-10-05
  • Date de publication de l'événement
    2010-12-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95082
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Cause
    There is the possibility for certain lots of the bd vacutainer push button blood collection sets to have separation of the cannula from the hub.
  • Action
    BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.

Device

BD Vacutainer Push Button collection Set
  • Modèle / numéro de série
    Catalog Number 367342; Lot numbers: 0145457, 0152300, 0153981, 0153982, 0158081, 0158082, 0158084, 0160664, 0160666, all exp 5/31/2012; Lot numbers 0165202, 0165205, 0165207, 0165218, 0165226, 0165227, 0165232, 0165234, 0176872, 0179208, 0179209, 0179212, 0180023, 0180026, 0180027, 0180028, 0180040, 0180042, all exp 6/30/2012; Lot numbers 0196209, 0196210, 0201399, 0201400, 0201402, 0208593, 0211641, all exp 7/31/2012.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    BD Vacutainer Push Button collection Set; || Non-Pyrogenic, Sterile, Rx only; || 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) || Becton Dickinson & Co., Franklin Lakes, NJ, USA || Intended use: Blood collection
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA