Medline Industries, LP — Class I: Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalo
Medline Industries, LP has initiated a Class I recall for specific Medline Convenience Kits due to potential fungal contamination of sterile applicators with Aspergillus penicillioides. The contamination is linked to certain environmental conditions that allow for fungal growth within the kits.
This recall affects Medline Industries, LP, healthcare facilities utilizing convenience kits DYKM1000B and DYKM2187A, and personnel responsible for sterile supply chain and infection prevention.
The classification as Class I indicates that the FDA believes there is a reasonable probability that exposure to the contaminated applicators will cause serious adverse health consequences or death, specifically systemic infection and sepsis. From a regulatory perspective, this suggests a significant failure in sterility assurance or environmental controls during the manufacturing or packaging process for these specific lots.
Immediate identification and quarantine of affected catalog numbers (DYKM1000B and DYKM2187A) are required. QA teams should evaluate current inventory for these specific sterile applicators and review supplier quality agreements regarding fungal contamination controls and environmental monitoring.
Class I. Reason: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.. Product: Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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