Medline Industries, LP — Class II: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Numbe
Medline Industries, LP is conducting a Class II recall for specific Micro-Kill Bleach Germicidal Bleach Wipes (Product Number MSC351450BG4) due to a potential reduction in bleach concentration below specification before the 12-month shelf life ends.
Medline Industries, LP; healthcare facilities and departments utilizing germicidal bleach wipes for environmental disinfection; and quality/regulatory personnel managing disinfectant stability.
A reduction in active ingredient concentration below established specifications directly compromises disinfection efficacy. This creates a regulatory and clinical risk where pathogenic microorganisms may survive on treated surfaces, potentially leading to healthcare-associated infections. This event highlights the criticality of robust stability testing and the need to monitor active ingredient degradation in chemical-based medical devices over their labeled lifecycle.
Quality teams should verify current inventory against the specified product number (MSC351450BG4) and assess existing shelf-life stability data for bleach-based disinfectants to ensure potency throughout the labeled duration. QA should also review complaint logs for reports of disinfection failure or microbial persistence.
Class II. Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.. Product: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov