Events

Rappel de Device Recall BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes

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
    76826
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1746-2017
  • Date de mise en oeuvre de l'événement
    2017-03-16
  • Date de publication de l'événement
    2017-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154356
  • 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
    Bd is initiating this product correction of multiple lots of bd vacutainer buffered sodium citrate: (9nc) blood collection tube (13x75 mm x 4.5 ml). a limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.
  • Action
    BD sent an "Urgent Product Correction Letters and Customer Product Correction Response Forms" dated March 16, 2017 via email or UPS to their customers and distributors.

Device

Device Recall BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes
  • Modèle / numéro de série
    Catalog Number: 367716 -  Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18  Catalog Number: 369714 -  Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18  Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - US Nationwide Distribution
  • Description du dispositif
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company || Product Usage: || The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
  • 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