Events

Recall of Zilver

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
    34162
  • Event Risk Class
    Class 2
  • Event Number
    Z-0391-06
  • Event Initiated Date
    2005-10-24
  • Event Date Posted
    2006-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43751
  • 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
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. the label front is correct.
  • Action
    Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.

Device

Zilver
  • Model / Serial
    Lot 1544171.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada.
  • Product Description
    Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA