Events

Rappel de Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer

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 Vascular Solutions, 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
    63098
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2400-2012
  • Date de mise en oeuvre de l'événement
    2012-08-30
  • Date de publication de l'événement
    2012-09-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112542
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Cause
    Vascular solutions, inc., became aware of a potential problem involving pouches missing a seal from guardian ii (model 8210) and guardian ii nc (model fh102) hemostasis valve which poses a risk of product contamination.
  • Action
    The firm, Vascular Solutions, sent an "URGENT - Medical Device Field Safety Notice" dated August 24, 2012 and a follow-up "Urgent Medical Device Removal - Lot Specific" letter dated August 30, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their inventory and to follow steps outlined in the letter which included to complete and return the "VSI Account Inventory Form" via email to: customerservice@vasc.com or fax: to (763) 656-4251. If you have specific questions or concerns regarding this matter, please contact your local Vascular Solutions Account Manager; call (763) 656 4300 or email: Senior Regulatory Operations Associate at SOuellette@vasc.com and/or email: www.vascularsolutions.com.

Device

Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer
  • Modèle / numéro de série
    lots 27686, 27293, 22446
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea
  • Description du dispositif
    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. || Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA