Home / Recalls / Ultroid Technologies, Inc. / Z-0782-2017

Z-0782-2017 Class II Terminated

Recalled by Ultroid Technologies, Inc. — Tampa, FL

Recall Details

Product Type: Devices
Report Date: December 28, 2016
Initiation Date: October 19, 2016
Termination Date: December 11, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,129

Product Description

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

Reason for Recall

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)

Distribution Pattern

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

Code Information

ALL serial numbers and lot numbers sold since 2003.