Events

Recall of Device Recall ZaStent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wilson-Cook Medical 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
    26966
  • Event Risk Class
    Class 2
  • Event Number
    Z-1180-03
  • Event Initiated Date
    2002-01-08
  • Event Date Posted
    2003-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28884
  • 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 inner catheter of the introducer system may break after stent deployment.
  • Action
    Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.

Device

Device Recall ZaStent
  • Model / Serial
    Reorder #ZABS-10-8-C, Amended 8/8/2003 to include: ZABS-10-4-C, ZABS-10-6-C
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed to hospitals located nationwide and worldwide.
  • Product Description
    Za-Stent Expandable Metal Biliary Stent
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • Manufacturer Address
    Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
  • Source
    USFDA