Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
1) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24GMD979; 2) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24FBM840; 3) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24HBK903
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →