Showing posts with label tattoo. Show all posts
Showing posts with label tattoo. Show all posts

Thursday, August 6, 2015

Tattoo inks and kit recalled due to life-threatening complication

Tattoo inks and kit recalled due to life-threatening complication
A Thousand Virgins Corp. in Miami, FL is recalling all lots of tattoo Inks described below due to microbiological contamination. A Thousand Virgins grey wash inks; G1, G2 and G3, that are labeled with Lot #129, and bearing the expiration date: 1/16, revealed contamination with Mycobacterium chelonae, Microbacterium organisms, and the molds Cryptococcus albidus and members of the Penicilliumgenus.
Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. The recalled products are described below:
Recalled Tattoo Inks (Sold in kits):
Brand:
Code:
Size:
Grey color shades G1,G2,G3
A Thousand Virgins
Grey Wash System
Lot No. 129
Expiration date: 01/16
2oz and 4oz bottles
The inks were manufactured, sold and distributed by A Thousand Virgins Corp. The G1, G2 and G3 grey wash tattoo inks were distributed nationwide and may be available for sale from international and online distributors.
As of today's date, there is no laboratory evidence matching microorganisms isolated from A Thousand Virgins tattoo inks to known cases of infection.
FDA Laboratory testing has found microbial contamination in the inks. Potentially pathogenic organisms were isolated and identified by the FDA.
This recall is being made with the knowledge of the US Food and Drug Administration. Consumers with any questions should contact us at 1-866-829-4659 from Monday to Friday between the hours of 9am to 5pm EST.
Product Photo, Front Label, A Thousand Virgins, G1,G2, G3

Friday, August 8, 2014

Inks Used in Certain Tattoo Kits Cause Infections

Inks Used in Certain Tattoo Kits Cause Infections (350x278)Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe.
But beware—there may be associated health risks.
Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks.
According to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection. “FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.”
Risks Can Be Severe
According to Katz, “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.”
She notes that injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo. Signs of localized infection include redness, swelling, weeping wounds, blemishes, or excessive pain at the site. If you experience any of these signs, seek medical care right away. Even after a localized infection has healed, the area may be permanently scarred.
Further, an infection that is left untreated or inadequately treated could spread through the bloodstream (a process known as sepsis). These infections may be associated with fever, shaking chills (rigors) and sweats. If these symptoms arise, treatment with antibiotics, hospitalization and/or surgery may be required.
Products Recalled, But Risk Remains
White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but FDA is still concerned that consumers and professional tattoo artists may be purchasing or using contaminated home tattoo kits and inks from other distributors.
Specifically, how can you identify kits and inks that you should not use because they may be contaminated? FDA advises you to watch out for inks intended for permanent makeup or traditional body tattoos that:
  • have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor,
  • are sold singly and in kits containing anywhere from five to 54, or perhaps more, bottles of inks of various colors, and
  • are marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.
“If you’re buying tattoo inks or getting a tattoo from a professional tattoo artist, you should first examine the products to determine whether the inks or kits meet the above descriptions,” cautions Katz.
FDA’s goal is to encourage consumers and tattoo and permanent make-up artists to take certain precautions and to urge potentially infected clients to seek medical care. “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,” says epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.
What to Do
Consumers and tattoo artists should do the following:
  • Seek immediate medical care if you experience any signs of infection.
  • Don’t use tattoo inks and kits that have no brand name, carry a dragon logo, and/or are missing the name and place of business of the manufacturer or distributor.
  • Dispose of tattoo inks that meet this description.
  • Do not use recalled kits.
  • Report adverse events or side effects through FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Tuesday, July 15, 2014

Recall of Tattoo Ink, Tattoo Needles, Tattoo kits Due to Microbial Contamination

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. The recall includes all tattoo inks, tattoo needles, and tattoo kits distributed by White & Blue Lion including the ones specifically listed below:
All Colors inks sold separately or in kits
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
Needles Individually packaged in groups of 5
Llabeled 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
The inks and needles are sold in tattoo kits and the inks are also sold separately by 8 Decades and White & Blue Lion, Inc. through www.amazon.com.
There was a report of one illness as of today’s date.
FDA Laboratory testing has found microbial bacterial contamination in both the inks and needles.
Consumers with any questions should contact us at 1-626-586-3485 from Monday to Friday between the hours of 9am to 6pm PST.
 White & Blue Lion, Inc. recalled tattoo ink photo 8
White & Blue Lion, Inc. recalled needles photo 1