Events

Recall of Universa Soft Ureteral Stent

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

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
    57352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0852-2011
  • Event Initiated Date
    2010-10-18
  • Event Date Posted
    2011-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95928
  • 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
    Ureteral Stent - Product Code FAD
  • Reason
    The firm received a customer complaint that a box labeled as universa firm stents but the box actually contained universa soft stents. the inner product label is correct but the outer box is wrong.
  • Action
    The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.

Device

Universa Soft Ureteral Stent
  • Model / Serial
    Lot number: U1987598.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.
  • Product Description
    Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. || Used for temporary internal drainage from the ureteropelvic junction to the bladder.
  • Manufacturer
    Vance Products Incorporated

Manufacturer

Vance Products Incorporated
  • Manufacturer Address
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA