Events

Recall of Device Recall Howell D.A.S.H. II Direct Access System

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
    27958
  • Event Risk Class
    Class 3
  • Event Number
    Z-0301-04
  • Event Initiated Date
    2003-12-17
  • Event Date Posted
    2004-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30798
  • 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
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) - Product Code KNS
  • Reason
    Wire-guided sphinterotomes may be packaged with an incorrect wire guide label.
  • Action
    Consignees were notified by letter sent via Certified Mail on December 17, 2003.

Device

Device Recall Howell D.A.S.H. II Direct Access System
  • Model / Serial
    Reorder Number: DASH-35-480, Lot Number: W1815864
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
  • Product Description
    Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • Manufacturer Address
    Wilson-Cook Medical Inc, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA