Events

Recall of Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating

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
    50223
  • Event Risk Class
    Class 2
  • Event Number
    Z-0980-2009
  • Event Initiated Date
    2008-11-10
  • Event Date Posted
    2009-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75002
  • 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
    Stent, ureteral - Product Code FAD
  • Reason
    "soft" stents were placed in "firm" stent outer boxes. the soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
  • Action
    Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.

Device

Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating
  • Model / Serial
    Lot Number: U1753668.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • Product Description
    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary 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