Chief Health Officer Advisory Queensland Department of Health Voluntary Recall of Tattoo Ink, Tattoo Needles, Tattoo Kits due to Microbial contamination Date Issued: 29 August 2014 Issued by: Dr Jeannette Young, Chief Health Officer, Queensland Issued to: All premises conducting tattooing Key messages This Public Health Advisory is for information only. The U.S. Food and Drug Administration has forwarded a voluntary nationwide product recall relating to Tattoo Ink, Tattoo Needles and Tattoo Kits distributed by White and Blue Lion Inc. White and Blue Lion, Inc. in the city of Industry, CA are 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 an extra precaution, all ink tubes and ink cups are being recalled. Consumers who may be concerned about the health risks of tattoo inks should discuss their concerns with their doctor. What is the issue? 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 There was a report of one illness as of 29 August 2014. 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: Bacillus 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. FDA Laboratory testing has found microbial bacterial contamination in both the inks and needles. This recall is being made with the knowledge of the US Food and Drug Administration. Any product should be disposed of by returning it to the supplier. What are the risks? These inks may contain a variety of potentially pathogenic organisms. For further specific product information see Table 1. Tattoo inks (sold in kits and separately) Brand Code Size All colours Multi coloured 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 Brand Codes Lot No. Expiration None – labelled as “CE0197 Pre-made tattoo needle” “sterilized by E.O. Gas” Art No. 1203RL, 1205M, 1205RL, 1205RS, 1209RL, 1207RL, 1207M, 1207RS, 1209M, 1209RS 201308, 201307, 201312, 201402, 201311, 201310 JUN2018 Prevention For tattoo premises: All premises conducting tattooing are advised to be aware of the recent recalls of tattoo inks, tattoo needles and tattoo kits in the US and ensure that they are not using these products. It is the responsibility of tattoo premises to ensure that they request a product quality data sheet (certificates of analysis or an equivalent statement) when purchasing inks from suppliers or directly from manufacturers to confirm that the product is safe and legal for use in Queensland. Under the Public Health (Infection Control for Personal Appearance Services) Act 2003, there is a requirement for all businesses involving tattooing to be registered with the local Council. The Public Health (Infection Control for Personal Appearance Services) Act 2003 set out the requirements that proprietors or occupiers of premises registered under the Public Health (Infection Control for Personal Appearance Voluntary Recall of Tattoo Ink, Tattoo Needles, Tattoo Kits due to Microbial contamination -2- Services) Act 2003 must observe. These include premises cleanliness and infection prevention and control measures for staff and equipment used. For consumers: Getting any tattoo carries some health risks. The safest way to get tattoos is from professional tattoo premises that are registered with your local council. Avoid getting tattoos in other countries (outside Australia), particularly in Asia, Africa, Eastern Europe and South America. It is recommended that consumers who may be concerned about health risks discuss their concerns with their doctor. More information For further information in Queensland, contact the relevant section of your local council, or the public health unit in your area. Contact details for the public health units can be found at www.health.qld.gov.au/cho/default.asp A copy of the USFDA recall notice can be found at www.fda.gov/Safety/Recalls/ucm405474.htm Attachment 1 contains the tattoo needles and tattoo inks referred to. Voluntary Recall of Tattoo Ink, Tattoo Needles, Tattoo Kits due to Microbial contamination -3-