FDA-Device2016-12-28Class II
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Ultroid Technologies, Inc.
Hazard
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)
Sold states
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
Affected count
1,129
Manufactured in
3140 W Kennedy Blvd Suite 103, N/A, Tampa, FL, United States
Products
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2017Don't want to check this manually?
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