Events

Rappel de PAXWIRE Occlusion Balloon 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 AccessClosure, Inc., A Cardinal Health 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
    75376
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0297-2017
  • Date de mise en oeuvre de l'événement
    2016-10-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150167
  • 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
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Cause
    Accessclosure, inc. (aci) is voluntarily recalling the paxwire occlusion balloon system device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. this is a deviation from the firm's standard catheterization technique.
  • Action
    Cardinal Health sent an Urgent Medical Device Field Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed complete the attached Field Action Return Response Form as soon as possible indicating the number of devices that have been used as their location and the number that will be returned. Customers should discuss the reimbursement for their purchased and return product with their sales representative, who will coordinate the process. Customers with questions were instructed to call 408-610-6570. For questions regarding this recall call 408-610-6500.

Device

PAXWIRE Occlusion Balloon System
  • Modèle / numéro de série
    Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution to FL and NJ
  • Description du dispositif
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
  • Manufacturer
    AccessClosure, Inc., A Cardinal Health Company

Manufacturer

AccessClosure, Inc., A Cardinal Health Company
  • Adresse du fabricant
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA