Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Medline Industries, LP
The hazard
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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) DYKM1000BModel UDI-DI: 10889942508143(each)Model 40889942508144(case)Model Lot Number: 24GMD979Model 2) DYKM2187AModel UDI-DI: 10195327628826(each)Model 40195327628827(case)Model Lot Number: 24FBM840Model 3) DYKM2187AModel Lot Number: 24HBK903UPC 10889942508143UPC 40889942508144UPC 10195327628826UPC 40195327628827Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.