Events

Recall of Ultroid Procedure Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ultroid Technologies, 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
    75055
  • Event Risk Class
    Class 2
  • Event Number
    Z-0784-2017
  • Event Initiated Date
    2016-10-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149386
  • 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
    Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 cfr 820 quality system regulation).
  • Action
    On October 19, 2016 Ultrid sent a recall letter to all their consignees informing them of the recall and to cease further distribution of this product, respond the self-addressed response form and returned for a voucher. For more information contact Melanie Rosario at 727-898-0717

Device

Ultroid Procedure Pack
  • Model / Serial
    ALL serial numbers and lot numbers sold since January 14, 2003.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam
  • Product Description
    Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
  • Manufacturer
    Ultroid Technologies, Inc.

Manufacturer

Ultroid Technologies, Inc.
  • Manufacturer Address
    Ultroid Technologies, Inc., 3140 W Kennedy Blvd Suite 103, Tampa FL 33609-3175
  • Manufacturer Parent Company (2017)
    Ultroid Technologies Inc.
  • Source
    USFDA