Infection Outbreak Leads to Home Tattoo Ink Kit Recall
Federal regulators are warning consumers that some home tattoo needles and ink kits sold on the internet may be unsafe, due to microbial contamination that may pose an infection risk.
An FDA consumer warning was issued on August 7, in the wake of a White & Blue Lion Inc. tattoo inks, needles and kits recall last month for all tattoo ink colors, needles individually packaged and packaged in groups of five, tattoo tubes and ink cups.
The recall was issued after FDA lab testing confirmed microbial bacterial contamination in both the inks and needles. One confirmed report of skin infection was identified after the consumer used the products in question. Other infections involving contaminated products with similar packaging have also been reported, but not officially linked to the recall.
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A variety of pathogenic organisms were isolated and identified in the products, ranging from gram negative bacteria, bacillus spp. Sphingomonas paucimobilis to clostridium botulinum.
The products are sold separately and in kits. They are sold by White & Blue and 8Decades online through Amazon and eBay. The kits are sold as in-home tattoo kits.
The contaminated products were recalled July 11, 2014, but officials say other distributers may still be selling the products, placing consumers at unnecessary risk.
Some of the recalled ink bottles have a multicolored Chinese dragon with black and white lettering. Others are missing manufacturer information.
“Tattooing poses a risk of infection to anyone, but the risk is particularly high for those with pre-existing heart or circulatory disease, diabetes or compromised immune systems,” said Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors.
Injecting contaminated ink into the skin or using contaminated needles may cause infections at the site of the tattoo. This may lead to redness, swelling, weeping wounds, blemishes, or excessive paint at the tattoo site.
Hepatitis, staph infections and the super bug MRSA have been tied to infections from tattoos. Typically this is a result of dirty needles or tools, in this case contaminated products.
Some people may experience an infection even after the tattoo site has healed, causing permanent scarring. The FDA has received reports of infection and adverse reactions years after a tattoo was done.
Health officials say the contaminants in White & Blue Lion inks and needles may lead to bacterial infection, which can also lead to sepsis. Sepsis is a potentially life-threatening complication of infection which spreads to the bloodstream.
Signs of sepsis may include fever, shaking, chills and sweats. Treatment may include antibiotics, hospitalization and surgery.
“Reporting an infection to FDA and the artist is important in order for FDA to investigate, and to enable the artist to take steps to prevent others from becoming infected,” said epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.
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AJuly 25, 2016 at 6:44 pm
My nephew was 16 and decide it was cool to get a home tattoo now he is dead from bad ink and needles. Please to all you kids out there wait until your 18 and get it done by a professional that includes piercings life is just too short to worry about that stuff especially nowadays..
amandaMarch 13, 2016 at 12:18 am
I got my tattoo bout 3yrs ago after bout 6 months it puffed up itched oozed. Went to numerous drs including skin specialist had biopsy done confirmed it was the tattoo ink. Been on steroids ever since. Due to being on those so long my bones have started to deterate. Just had shoulder replacement surgery 3wks ago.
KariJune 20, 2015 at 8:04 pm
I was hoping I could get pointed in the right direction. My father-in-law got a tattoo with White and Blue Lions Ink, and needles. He is on his death bed as we speak. He's been to the ER twice in the last 3 days. We didn't know what was wrong with him. Until someone brought to our attention the recall. He is stacking up medical bills. Missing work. We don't know what to do from here on out. He has[Show More]I was hoping I could get pointed in the right direction. My father-in-law got a tattoo with White and Blue Lions Ink, and needles. He is on his death bed as we speak. He's been to the ER twice in the last 3 days. We didn't know what was wrong with him. Until someone brought to our attention the recall. He is stacking up medical bills. Missing work. We don't know what to do from here on out. He has a compromised immune system to begin with.
FeatherSeptember 15, 2014 at 2:48 am
I think I may have used the recalled product I had a rash appear in July on the locations I used the product itchy bumps that scab and peel and even ooze a little.I thought it went away but one rash has come back in the same place. I have shiny scarring around one of tattoos. But it does not spread it stays right near and on the tattoo. This is not my first tattoo either. I attempted to contact th[Show More]I think I may have used the recalled product I had a rash appear in July on the locations I used the product itchy bumps that scab and peel and even ooze a little.I thought it went away but one rash has come back in the same place. I have shiny scarring around one of tattoos. But it does not spread it stays right near and on the tattoo. This is not my first tattoo either. I attempted to contact the seller through Amazon and guess what the company is closed. Literally the email I got said. "This company is closed. LArry" so no one can confirm whether my product is the recall. It does match the description but I was hoping before I racked up thousands getting needles, ink and myself tested. That someone could tell me for sure that it was or was not the product. But I will be calling the Health Dept tomorrow and if need be a lawyer. I think since the manufacturer information is missing they should be sued regardless.Oh and Amazon didnt even contact me about the recall I found out through a friend. The amazon rep had no idea anything had been recalled. You would think even though its a third party it coming through amazon to be sold they would have some responsibility. Oh and I might get a partial refund, how generous.
pamelaSeptember 10, 2014 at 6:10 pm
this is not my first tattoo. i have over 15 tattoos with no problems until these tats with this product.
pamelaSeptember 2, 2014 at 5:13 pm
I have numerous tattoos. The one with the said product looked awesome for about 9 months, the it started to swell, itch n get scabs( peeling). Has scarring around it.
MatthewAugust 19, 2014 at 4:13 pm
Used this product to give myself a tattoo, scarred up and looks horrible. This isn't my first tattoo, and I know proper tattoo after care. All of my other tattoos look flawless compared to this one.
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