Medline Convenience Kits Recalled for Potential Fungal Contamination
Medline Industries is recalling 1,100 convenience kits nationwide 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the contamination may lead to death, which triggers the Critical severity score per the rubric.
Plain-English summary
Medline Industries, LP is recalling 1,100 Medline Convenience Kits (catalog numbers DYNDH1193 and DYNDH1487A) distributed nationwide. The recall involves specific lots of sterile applicators that may contain fungal contamination.
The contamination involves Aspergillus penicillioides, which may grow under certain environmental conditions. The FDA notes that 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 stop using the affected kits and contact Medline Industries for a refund or replacement. The affected lots are identified by specific UDI-DI and lot numbers listed in the official recall notice.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,100
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 (10)
- 1) DYNDH1193
- UDI-DI: 10889942499953(each)
- 40889942499954(case)
- Lot Number: 24HBF076
- 2) DYNDH1193
- Lot Number: 24HBU638
- 3) DYNDH1487A
- UDI-DI: 10193489484311(each)
- 40193489484312(case)
- Lot Number: 24FMH485
Distribution
Distributed nationwide across the United States.
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