Retiro De Equipo (Recall) de Device Recall Harris Medical UV Lamp

Recall

55724

Class 2

Z-1808-2010

2010-05-13

2010-06-16

Terminated

United States

2010-12-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91667

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.

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.