Medline Industries, LP: Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-08-11
- Code info
- 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
- Product quantity
- 2718 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 99669
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