Medline Convenience Kits Recalled for Fungal Contamination Risk
Medline is recalling 10,407 convenience kits containing sterile applicators that may be contaminated with Aspergillus penicillioides, posing a risk of serious infection.
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 systemic infection, sepsis, and death, which aligns with the rubric criteria for a Severe (Score 4) recall involving significant injury or death reports/risks.
Plain-English summary
Medline Industries, LP is recalling 10,407 convenience kits distributed nationwide. The affected products include seven specific catalog numbers: ACC010308A, ACC010374A, ACC010679, ACC010726A, DYNDB3061, DYNDH1245, and DYNDH1362. Specific lot numbers and UDI-DI codes for these kits are listed in the official recall record.
The recall is due to the potential presence of fungal contamination in the sterile applicators contained within the kits. Under certain environmental conditions, the fungus Aspergillus penicillioides may grow. Contamination of skin preparation products with this fungus may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Consumers and healthcare facilities should check their inventory for the specific catalog numbers and lot numbers identified in the recall. If the affected products are found, they should be removed from use and returned to Medline Industries, LP or the original supplier for credit or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number…
- Manufacturer
- Medline Industries, LP
- Affected units
- 10,407
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 (20)
- 1) ACC010308A
- UDI-DI: 10889942424597(each)
- 40889942424598(case)
- Lot Number: 24HDA993
- 2) ACC010308A
- Lot Number: 24IDB285
- 3) ACC010308A
- Lot Number: 24JDA212
- 4) ACC010374A
- UDI-DI: 10193489893977(each)
- 40193489893978(case)
- Lot Number: 24IDB849
- 5) ACC010679
- UDI-DI: 10195327396268(each)
- 40195327396269(case)
- Lot Number: 24HDA071
- 6) ACC010726A
- UDI-DI: 10198459043666(each)
- 40198459043667(case)
- Lot Number: 24GDB143
Distribution
Distributed nationwide across the United States.
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