FDA-Device2026-09-23Class IPROCESSING DEFECT

Medline Convenience Kits recalled for fungal contamination in sterile applicators

OTHERNationwide distributionMedical devices

What this means

Certain lots of sterile applicators in Medline Convenience Kits may contain fungal contamination (Aspergillus penicillioides) that could grow under certain environmental conditions. This contamination can cause serious infections including sepsis.

  • Check if you have Medline Convenience Kit model DYKM1000B (Lot 24GMD979) or DYKM2187A (Lots 24FBM840 or 24HBK903)
  • Do not use affected kits for skin preparation
  • Contact Medline Industries or your healthcare provider if you have used an affected kit
  • Return unused kits to your supplier or Medline for a refund
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
2718 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3125-2026

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