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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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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