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U.S. Department of Health and Human Services

Class 2 Device Recall I Color

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 Class 2 Device Recall I Colorsee related information
Date Initiated by FirmSeptember 10, 2014
Date PostedJanuary 12, 2015
Recall Status1 Terminated 3 on October 07, 2019
Recall NumberZ-0951-2015
Recall Event ID 69419
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductLabeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) Product Usage - Eye contact lens
Code Information ALL LOTS / CODES
Recalling Firm/
Manufacturer		 Intertrade Imports Inc.
4227 Clinton Ave
Jacksonville FL 32207-6852
For Additional Information ContactSam Savvidis
904-730-7796
Manufacturer Reason
for Recall		A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.
FDA Determined
Cause 2		Material/Component Contamination
ActionThe firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.
Quantity in Commerce2850 each
DistributionWorlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Total Product Life CycleTPLC 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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