Tampa, FL (PRWEB) September 27, 2016
Ultroid Technologies (http://ultroid.com) announced today that it is recalling all Ultroid Hemorrhoid Management System (UHMS) Device kits, Procedure Packs, and individual replacement parts manufactured on or after February 27, 2003 as these devices may not have been designed, qualified, manufactured, and/or managed under a state of control per internal quality assurance procedures and US regulations, such as the US FDA Quality System Regulation for medical device manufacturers.
Customers with questions regarding this issue can contact Ultroid Recall Hotline at 877.858.0555. For additional information customers should go to the following website: http://ultroidrecall.com.
While there have been no reports of adverse reactions associated with the use of UHMS in the United States, factors associated with failures to manufacture products with documented Good Manufacturing Practices as defined by the US Food and Drug Administration, an ineffective Quality Management System, and poor supplier management practices leads to the conclusion that the overall severity risk associated with the use of these devices is serious, taking into consideration that it cannot be verified by objective evidence that the devices are manufactured in accordance with the specifications cleared by the FDA. These events have led to an unacceptable risk requiring removal of the UHMS.
As part of its commitment to ensuring the safety of patients, Ultroid has reported these device concerns to the U.S. Food and Drug Administration and is conducting a thorough investigation into these events.
Ultroid advises healthcare providers to not use the Ultroid Hemorrhoid Management System Device on any patients and return all Ultroid Hemorrhoid Management System Devices (including components and accessories) either back to the distributor or Ultroid Technologies, Inc.
Patients should have periodic examinations by their physicians after undergoing coagulative hemostatic therapy using the Ultroid Hemorrhoid Management System Device.
Ultroid Technologies, Inc. manufactures and markets the Ultroid® Hemorrhoid Management System (“Ultroid® System”). The Ultroid® System, which is FDA cleared and also approved for use in many other nations, is a non-surgical, non-anesthetic, and rapid treatment for hemorrhoidal disease (HD).
The Ultroid® System is covered by most major insurers and Medicare, and has been successfully utilized in an estimated 155,000 procedures, by several hundred physicians, practices, clinics, and surgical centers. The Ultroid® procedure is currently offered in over 150 clinics in the US and was introduced in UK in 2013 where it is currently offered in 11 clinics.