Blaine Labs, Inc. announced on Apr. 8 a voluntary nationwide recall of certain lots of its Wound Care Gel products after testing found microbial contamination by Lysinibacillus fusiformis.
The recall affects both the Revitaderm and Tridergel Wound Care Gels in 1 oz. and 3 oz. sizes, which are used as topical antiseptics for minor cuts, scrapes, and burns. The company said the affected products were distributed to healthcare providers across the United States but were not sold through retail or internet channels.
Lysinibacillus fusiformis is described as an environmental, spore-forming bacterium that typically has low pathogenicity in healthy individuals but can pose risks to those with open wounds or weakened immune systems. According to Blaine Labs, "Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing." The company also warned that infections could become severe in some cases: "In immunocompromised individuals... these infections may become severe and lead to life-threatening complications such as endocarditis or central system infection."
No reports of adverse events related to this recall have been received so far by Blaine Labs.
Customers and healthcare providers are advised to check their inventory for the affected lot numbers listed by Blaine Labs and discontinue use immediately. Any remaining inventory should be segregated and arrangements made with the company for return of the product.
Consumers with questions about the recall can contact Blaine Labs at (800) 307-8818 during business hours or email Contact@blainelabs.com. Adverse reactions can also be reported directly to the Food and Drug Administration's MedWatch program online at www.fda.gov/medwatch/report.htm.
Blaine Labs stated that it is notifying physician clinics by mail and phone regarding this recall process.
