Medline Convenience Kits Recalled for Fungal Contamination Risk
Medline Industries is recalling 447 convenience kits nationwide due to potential fungal contamination that could cause serious health consequences.
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 'Severe' criteria for significant injury or property-damage reports and high-risk pathogens.
Plain-English summary
Medline Industries, LP is recalling 447 units of two specific convenience kits: the Port Access Kit (Catalog Number DYKM1414) and the Arterial Line St Joes Syr Pack (Catalog Number DYNJ38145F). The affected lots are 24HBS933 and 24HBT600, respectively. These products were distributed nationwide in the United States.
The recall was initiated because the kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides, a type of fungus. This contamination may occur under specific environmental conditions. The presence of this fungus in skin preparation products poses a risk of serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Healthcare facilities and consumers who have these specific catalog numbers and lot numbers should stop using the products immediately. They should contact Medline Industries for further instructions on how to return or dispose of the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 447
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) DYKM1414
- UDI-DI: 10889942481293(each)
- 40889942481294(case)
- Lot Number: 24HBS933
- 2) DYNJ38145F
- UDI-DI: 10193489277173(each)
- 40193489277174(case)
- Lot Number: 24HBT600
Distribution
Distributed nationwide across the United States.
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