Events

Rappel de Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA

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 & Co..

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
    53961
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1008-2010
  • Date de mise en oeuvre de l'événement
    2009-11-11
  • Date de publication de l'événement
    2010-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86951
  • 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
    system, blood culturing - Product Code MDB
  • Cause
    The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
  • Action
    An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
  • Modèle / numéro de série
    9233240 exp 6/30/2010 9233261 exp 6/30/2010 9233263 exp 6/30/2010 9257241 exp 6/30/2010 9257242 exp 6/30/2010 9257243 exp 6/30/2010 9257245 exp 6/30/2010 9267148 exp 7/31/2010 9267150 exp 7/31/2010 9267151 exp 7/31/2010 9267152 exp 7/31/2010 9267153 exp 7/31/2010 9267154 exp 7/31/2010 9267155 exp 7/31/2010 9267156 exp 7/31/2010 9267161 exp 7/31/2010 9267163 exp 7/31/2010 9267165 exp 7/31/2010 9267167 exp 7/31/2010 9267169 exp 7/31/2010 9267171 exp 7/31/2010 9268355 exp 7/31/2010 9268356 exp 7/31/2010 9299501 exp 8/31/2010
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
  • Description du dispositif
    BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** || BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA