Events

Recall of Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HK Surgical 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
    31878
  • Event Risk Class
    Class 2
  • Event Number
    Z-0900-05
  • Event Initiated Date
    2004-12-03
  • Event Date Posted
    2005-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38661
  • 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
    Needle, Fistula - Product Code FIE
  • Reason
    Risk of hubs becoming disconnected from the cannula.
  • Action
    Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.

Device

Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM1...
  • Model / Serial
    All Codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.
  • Product Description
    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
  • Manufacturer
    HK Surgical Inc

Manufacturer

HK Surgical Inc
  • Manufacturer Address
    HK Surgical Inc, 30280 Rancho Viejo Rd, San Juan Capistrano CA 92675-1561
  • Source
    USFDA