Medline Anesthesia Kits Recalled for Fungal Contamination Risk
Medline is recalling specific lots of Anesthesia L&D A-Line Sets due to potential Aspergillus penicillioides contamination in sterile applicators.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the contamination may lead to serious adverse health consequences, including death, which aligns with the rubric criteria for Severe (score 4) involving significant injury or death reports/risks.
Plain-English summary
Medline Industries, LP is recalling 12 kits of the KIT ANESTHESIA L&D A- LINE SET (Catalog Number: DYKMBNDL199A). The recall affects specific lots distributed nationwide in the United States.
The recall is issued because the kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides. This fungal contamination can occur under certain environmental conditions. The source text states that contamination of skin preparation products with this fungus may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Healthcare facilities and consumers who possess these specific kits should stop using them and contact Medline Industries, LP for further instructions or a return.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Anesthesia Kits
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) DYKMBNDL199A
- UDI-DI: 10193489848540(each)
- 40193489848541(case)
- Lot Number: 24HBH109
- 2) DYKMBNDL199A
- Lot Number: 24HBM182
- 3) DYKMBNDL199A
- Lot Number: 24HBS365
Distribution
Distributed nationwide across the United States.
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