Events

Rappel de Arstasls One Access System

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 Arstasis, 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
    57507
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0993-2011
  • Date de mise en oeuvre de l'événement
    2010-10-19
  • Date de publication de l'événement
    2011-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96420
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Device has the potential to fracture and sheath separation during use.
  • Action
    The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.

Device

Arstasls One Access System
  • Modèle / numéro de série
    Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft || and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA || The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.
  • Manufacturer
    Arstasis, Inc

Manufacturer

Arstasis, Inc
  • Adresse du fabricant
    Arstasis, Inc, 740 Bay Rd, Redwood City CA 94063-2469
  • Société-mère du fabricant (2017)
    Arstasis Inc.
  • Source
    USFDA