Events

Rappel de Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine 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
    64494
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1056-2013
  • Date de mise en oeuvre de l'événement
    2013-02-14
  • Date de publication de l'événement
    2013-04-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116319
  • 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, specimen, sterile - Product Code FMH
  • Cause
    The bd vacutainer urinalysis transfer straw kit #364991, lot 1335484 has preprinted polybags which are incorrectly labeled as catalog #364953. bd advises any customer who purchased this kit that the tube in this kit is not a c&s; tube. if a customer relies solely on the polybag labeling and uses the tube inside the kit for the purpose of collecting urine for culture and sensitivity, it is possible.
  • Action
    BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.

Device

Device Recall BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube
  • Modèle / numéro de série
    Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
  • Description du dispositif
    BD Vacutainer C&S; Transfer Straw Kit C&S; Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, || The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
  • 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