Status:
Resolved
Health alert:
140008
Date Issued:
29 Aug 2014
Issued by:
Dr Rosemary Lester Chief Health Officer, Victoria
Issued to:
All premises conducting tattooing

Key messages

  • This advisory does not refer to a current Australian product recall and is for information only.
  • The US Food and Drug Administration have announced a Voluntary Nationwide Recall of tattoo ink, tattoo needles, tattoo kits due to microbial contamination. White & Blue Lion, Inc. is recalling products due to bacterial contamination. Use of these products may cause serious infection and can lead to sepsis, a potentially life-threatening complication of an infection.
  • All premises conducting tattooing are advised to be aware of the US recall of tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion and ensure that they are not using these products.

What is the issue?

White & Blue Lion, Inc. in the City of Industry, CA is recalling tattoo inks, tattoo needles and tattoo kits due to bacterial contamination. US Food and Drug Administration (FDA) Laboratory testing has found bacterial contamination in both the inks and needles.

Use of these products may cause serious infection and can lead to sepsis, a potentially life-threatening complication of an infection. The recall includes all tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion. Refer to table 1 on the following page.

The inks and needles are sold in tattoo kits and the inks are also sold separately by 8Decades and White & Blue Lion, Inc. through Amazon & Ebay.

There has been one reported case of illness overseas.

Table 1: White & Blue Lion, Inc recalled products

Tattoo inks (sold in kits and separately) Brand Code Size
All colours 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) Brand Codes Lot no. Expiration
Individually packaged in groups of 5 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
JUN 2018
Who is at risk?

There may be a health risk for individuals receiving tattoos with these products.

Prevention

Tattoo premises

All premises conducting tattooing are advised to be aware of the FDA US recall of tattoo ink, tattoo needles, tubes, ink cups and kits distributed by White & Blue Lion and ensure that they are not using these products.

Tattoo premises are reminded that it is the responsibility of 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 Victoria.

Under the Public Health and Wellbeing Act 2008 there is a requirement for all businesses involving tattooing to be registered with the local Council.  The Public Health and Wellbeing Regulations 2009 set out the requirements that proprietors or occupiers of premises registered under the Public Health and Wellbeing Act 2008 must observe. These include premises cleanliness and infection prevention and control measures for staff and equipment used.

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 in Australia. Avoid getting tattoos overseas, particularly in Asia, Africa, Eastern Europe and South America.