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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 24, 2006
Date Posted June 08, 2006
Recall Status1 Terminated 3 on January 22, 2008
Recall Number Z-0451-06
Recall Event ID 35548
Product Classification unknown device name - Product Code U28
Product PlusRite Low Watt Metal Halide Lamps
Code Information N/A
Recalling Firm/
Manufacturer		 Fanlight Corporation Inc
14145 Proctor Ave Ste 14
City Of Industry CA 91746-2841
For Additional Information Contact Linda Liu
909-392-7328 Ext. 104
Manufacturer Reason
for Recall		 These non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3
FDA Determined
Cause 2		 Other
Action 1.Fanlight Corporation, Incorporated shall notify all dealers and purchasers requesting that the recipients forward a copy of the letter on to each recipient''s customers, with the objective of notifying as many end users as possible. Fanlight at no cost to the purchaser will bring the units into compliance
Quantity in Commerce 100,000 total for all 5 products
Distribution Nationwide
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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