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U.S. Department of Health and Human Services

Class 2 Device Recall Harris Medical UV Lamp

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  Class 2 Device Recall Harris Medical UV Lamp see related information
Date Initiated by Firm May 13, 2010
Date Posted June 16, 2010
Recall Status1 Terminated 3 on December 10, 2010
Recall Number Z-1808-2010
Recall Event ID 55724
Product Classification Medical ultra-violet (UV) Lamp - Product Code MXG
Product Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"
Code Information All models, serial numbers and lot numbers are subject to this recall.
Recalling Firm/
Manufacturer		 Harris Medical Resources
3535 W Irving Park Rd
Chicago IL 60618-3219
For Additional Information Contact Mr. Thomas M. Perez
773-583-7500
Manufacturer Reason
for Recall		 The Harris UV Lamp was promoted for sub-lingual treatment of HIV/AIDS; Hepatitis B; Hepatitis C; Malaria, Typhoid, Amoeba Infections and other blood diseases. The product was marketed without a 510(k), or an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). Questions are directed to the firm at 773-583-7500.
FDA Determined
Cause 2		 PMA
Action Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.
Quantity in Commerce 20 units
Distribution Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru
Total Product Life Cycle TPLC 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.
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