Events

Rappel de BD Vacutainer Plus Plastic Citrate Blood Collection Tube

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
    79901
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2258-2018
  • Date de mise en oeuvre de l'événement
    2018-04-11
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163868
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Cause
    Approximately 3.4% of bd vacutainer plus plastic citrate blood collection tubes (2.7ml) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
  • Action
    BD began notifying distributors on April 11, 2018. Customer communications were mailed on April 12-13th, 2018. US customers will be sent a letter via UPS beginning April 12, 2018. Distributors were e-mailed on April 11, 2018 and requested that they provide a list of their consignees to facilitate mailing to end users BD Regions will be contacted via email regarding distribution outside of the US Distributors were instructed to return customer lists to BD. Letters will be mailed with UPS tracking, which provides for a 100% effectiveness check. Customer response form will be tabulated. 100% of non-responders will be contacted by phone.

Device

BD Vacutainer Plus Plastic Citrate Blood Collection Tube
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.
  • Description du dispositif
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.
  • 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