Events

Recall of Device Recall Ultraxx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73398
  • Event Risk Class
    Class 2
  • Event Number
    Z-1237-2016
  • Event Initiated Date
    2016-01-27
  • Event Date Posted
    2016-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144043
  • Notes / Alerts
    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.
  • Extra notes in the data
    Catheter, nephrostomy - Product Code LJE
  • Reason
    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
  • Model / Serial
    Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • Product Description
    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.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA