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U.S. Department of Health and Human Services

Class 2 Device Recall Ultroid Mobile Generator/Battery

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 Class 2 Device Recall Ultroid Mobile Generator/Batterysee related information
Date Initiated by FirmOctober 19, 2016
Create DateDecember 17, 2016
Recall Status1 Terminated 3 on December 11, 2019
Recall NumberZ-0783-2017
Recall Event ID 75055
510(K)NumberK023706 K030315 
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
ProductUltroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Code Information ALL serial numbers and lot numbers sold since January 14, 2003.
Recalling Firm/
Manufacturer		 Ultroid Technologies, Inc.
3140 W Kennedy Blvd Suite 103
Tampa FL 33609-3175
For Additional Information ContactGeorge Calafactor
727-898-0717
Manufacturer 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)
FDA Determined
Cause 2		Process control
ActionOn October 19, 2016 Ultrid sent a recall letter to all their consignees informing them of the recall and to cease further distribution of this product, respond the self-addressed response form and returned for a voucher. For more information contact Melanie Rosario at 727-898-0717
Quantity in Commerce62 units
DistributionAL, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNS
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