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Z-0784-2017 Class II Terminated

Recalled by Ultroid Technologies, Inc. — Tampa, FL

FDA device recall Z-0784-2017 was initiated by Ultroid Technologies, Inc. on October 19, 2016 and is designated Class II. 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 guidanc… The recall status is terminated (terminated December 11, 2019). Affected quantity: 52,084.

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: 52,084

Product Description

Ultroid Procedure Pack including the Ultroid Sterile Disposable 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 January 14, 2003.