COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Cosmetics
- Reason for Announcement:
-
Recall Reason Description
Contaminated with high concentrations of microorganisms
- Company Name:
- Sierra Stain LLC
- Brand Name:
- Product Description:
-
Product Description
Water Based Tattoo Pigments
Company Announcement
Sierra Stain LLC of Carson City, Nevada is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. Commonly reported symptoms of tattoo ink associated infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Symptoms can be difficult to recognize, as other conditions (e.g. allergic reactions) may also present with similar findings.
|
Product Label |
Manufacturing Codes |
Microorganisms Identified |
|---|---|---|
| Bloodline 1/2oz/15mL CAROLINA BLUE Water Based Tattoo Pigments |
Batch #1 Lot BL23 Manufactured 07/01/23 Expires 07/01/26 |
Citrobacter braakii Citrobacter farmer Pseudomonas fluorescens Achromobacter xylosoxidans Ochrobactrum anthropic Cupriavidus pauculus |
| Bloodline 1oz/30mL ALL PURPOSE BLACK Water Based Tattoo Pigments |
Batch #1 Lot BL23 Manufactured 07/01/23 Expires 07/01/26 |
Acetobacter senegalensis |
| Bloodline 1/2oz/15mL UV CHINA PINK Water Based Tattoo Pigments |
Batch #1 Lot SC23 Manufactured 06/23 Expires 06/26 |
Curtobacterium citreum/pusillum |
Products are packaged in plastic rounded bullet shape PET bottles with black dispense screw top and were distributed to all 50 states through Amazon.
No illnesses have been reported to date.
Reason for recall: The recall was initiated after the recalling firm became aware of the results of the samples collected and analyzed by FDA, which tested positive for multiple microorganisms.
Tattoo artists and retailers should avoid using or selling the recalled tattoo inks and dispose product in a sharps container or a similar biohazard container. SDS info is available upon request.
Tattoo artists should be working in a professional environment such as a Tattoo Shop, as tattooing from home carries high risk of contamination in unsanitary conditions. Tattoo inks alone may not be the sole cause of adverse reactions, if not applied in a safe environment by professionals.
Consumers should also consider reporting their injury to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program. The FDA encourages consumers with questions about product safety to submit an inquiry, or to visit www.fda.gov/fcic for additional information.
Bloodline inks and Sierra Stain LLC are no longer in business and not manufacturing tattoo ink products. For questions contact sierrastain@gmail.com.
