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Class 2 Device Recall Ultroid Sterile Disposable Probes |
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Date Initiated by Firm |
October 19, 2016 |
Create Date |
December 17, 2016 |
Recall Status1 |
Terminated 3 on December 11, 2019 |
Recall Number |
Z-0785-2017 |
Recall Event ID |
75055 |
510(K)Number |
K023706 K030315
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Product Classification |
Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
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Product |
Ultroid Sterile Disposable Probes sold individually |
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
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For Additional Information Contact |
George Calafactor 727-898-0717
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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)
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FDA Determined Cause 2 |
Process control |
Action |
On 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 Commerce |
7,784 |
Distribution |
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 |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KNS and Original Applicant = ULTROID, LLC
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