Ultroid Technologies, Inc. recalls Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

Recall date

October 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0782-2017

FDA classification

Class II

Brand / firm

Ultroid Technologies, Inc.

Sold / distributed

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,…

Why it was recalled

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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes