Voluntary recall of tattoo Ink, needles, kits due to microbial contamination

Voluntary recall of tattoo Ink, needles, kits due to microbial contamination

Voluntary recall of tattoo Ink, needles, kits due to microbial contamination

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by FDA

WHAS11.com

Posted on August 18, 2014 at 10:54 AM

(FDA) -- White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion including the ones specifically listed below:

Tattoo Inks (sold in kits and separately)

Multi colored Chinese Dragon Image with black and white lettering     Lot No. OR20036
Batch #8
Best if used by 16/12/16    
5 ml bottle

 
Tattoo Needles (included in kits)    

Individually packaged in groups of 5    
Labeled as “CE0197 Pre-made tattoo needle” “sterilized by E.O. Gas”    
Art No. 1203RL, 1205M, 1205RL, 1205RS, 1209RL, 1207RL, 1207M, 1207RS, 1209M, 1209RS    
Lot No. 201308, 201307, 201312, 201402, 201311, 201310    
Expiration June 2018


The inks and needles are sold in tattoo kits and the inks are also sold separately by 8Decades and White & Blue Lion, Inc. through www.amazon.com & www.ebay.com

There was a report of one illness.

FDA Laboratory testing has found microbial bacterial contamination in both the inks and needles.

From the tattoo kits (ink and needles) a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacilllus spp. Sphingomonas paucimobilis, Micrococcus lutes, Corynebacterium spp., Clostridium botulinum and other Clostridium spp. No Mycobacteria were isolated.

From the ink sets a variety of potentially pathogenic organisms were isolated and identified including: Gram negative bacteria, Gram positive rods and cocci, which when identified to the genus and species levels included: Bacillus spp, Acinetobacter spp., Staphylococcus haemolyticus, Sphingomonas paucimobilis. No Mycobacteria were isolated.

This recall is being made with the knowledge of the US Food and Drug Administration.

Consumers with any questions should contact us at 1-626-586-3485 from Monday to Friday between the hours of 9 a.m. to 6 p.m. PST.

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