Events

Rappel de Device Recall Ultraxx

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 Cook 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
    73398
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1237-2016
  • Date de mise en oeuvre de l'événement
    2016-01-27
  • Date de publication de l'événement
    2016-03-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144043
  • 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, nephrostomy - Product Code LJE
  • Cause
    Cook medical is voluntarily recalling specific lots of the ultraxx" nephrostomy balloon set and the ascend¿ aq¿ ureteral dilation balloon catheter set because of a labeling mix-up. cook medical has received reports of packages labeled as ultraxx" nephrostomy balloon set actually containing the ascend¿ aq¿ ureteral dilation balloon catheter set and vice versa.
  • Action
    Cook Medical sent an Urgent Medical Device Recall Notification letter dated January 27, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to quarantine any unused affected product. Immediately collect and return all unused affected products to Cook Medical If you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235. For questions regarding this recall call 800-457-4500.

Device

Device Recall Ultraxx
  • Modèle / numéro de série
    Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • Description du dispositif
    UltraxxTM Nephrostomy Balloon Set || The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA