White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles

August 8, 2014

Audience: Dermatology, Primary Care Provider, Nursing

[Posted 08/08/2014]

ISSUE: FDA is notifying health professionals and their patients of the voluntary recall of White and Blue-branded tattoo inks and needles due to confirmed bacterial contamination in unopened bottles of inks and on needles included in tattoo kits. FDA is concerned that consumers are continuing to use contaminated inks for tattoos. Similarly packaged tattoo products remain available online and may be marketed by other distributors from the same manufacturer.

Injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo that can spread throughout the body through blood. Symptoms of illness include redness, swelling, itching, or blemishes in the tattoo, or pain in the tattoo that does not go away.These infections can be severe and require extensive treatment with antibiotics, hospitalization, or surgery. Sepsis, a potentially life-threatening body-wide infection of the blood, may result. Once the infection has healed, the area may remain permanently scarred. Anyone receiving a tattoo is at risk for infection, but particularly vulnerable are those with pre-existing heart or circulatory disease, diabetes, or patients with compromised immune systems.

BACKGROUND: On July 11, 2014, White and Blue Lion, Inc. recalled tattoo inks sold separately and in kits, and tattoo needles in kits. See firm press release for lot and batch numbers. The inks carry a dragon logo on the packaging. The contaminated inks are sold singly and in sets containing from five to 54 or more bottles of ink of various colors. The contaminated inks are also sold in kits containing needles and tattooing machines. Some of the sets are intended for permanent makeup, as well as for traditional body tattoos. Containers may be marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.

RECOMMENDATION: FDA is warning consumers not to use tattoo inks and tattoo kits that have been recalled or that have similar packaging to those that have been recalled. Consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the inks and/or kits are part of the recall.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/07/2014 - Consumer Update - FDA] 
[08/07/2014 - Constituent Update - FDA/CFSAN] 
[08/07/2014 - Product Photos - FDA]
[07/15/2014 - Firm Press Release - White and Blue Lion, Inc.]
 

View comments

Hide
(web4)