Date Initiated by Firm | March 24, 2006 |
Date Posted | June 08, 2006 |
Recall Status1 |
Terminated 3 on January 22, 2008 |
Recall Number | Z-0453-06 |
Recall Event ID |
35548 |
Product Classification |
unknown device name - Product Code U28
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Product | PlusRite Protected Metal Halide Lamps |
Code Information |
N/A |
Recalling Firm/ Manufacturer |
Fanlight Corporation Inc 14145 Proctor Ave Ste 14 City Of Industry CA 91746-2841
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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 |
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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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