Voluntary recall: tattoo ink needles and kits

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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
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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
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