FDAFDA · Food and drugs·Recall number Z-0783-2017
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Published December 28, 2016 · Recall initiated: October 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultroid Technologies, Inc.
- Distributor
- 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
- Lot
- ALL serial numbers and lot numbers sold since January 14, 2003.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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