Events

Rappel de Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Chamber and Bard EXLok Sampling

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 C.R. Bard, Inc..

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
    70666
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1358-2015
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • Date de publication de l'événement
    2015-04-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134365
  • 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
    Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
  • Cause
    Potential breach of the sterile barrier packaging.
  • Action
    Bard sent an Urgent Medical Device Recall letter on January 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter also requested that a sub-recall should be conducted if the product was further distributed. The letter also included a response form which is to be returned to Bard. This voluntary recall is only for the lots noted above with the affected product catalog number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you have further distributed this product, you are required to notify your accounts of the voluntary recall. If you have any questions or need assistance in notifying your accounts about the correction, please call 1-770-784-6471. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.

Device

Device Recall Bard 100 LatexFree Urinary Drainage Bag with AntiReflux Chamber and Bard EXLok Sam...
  • Modèle / numéro de série
    Lot Numbers NGYJ0603 and NGYJ1671
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.
  • Description du dispositif
    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Adresse du fabricant
    C.R. Bard, Inc., 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA