Medline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
Medline is recalling 47,848 blood and urine collection kits nationwide because they may contain Aspergillus penicillioides, a fungus that can cause serious infection.
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 (5) per the rubric criteria for known fatalities or death reports.
Plain-English summary
Medline Industries, LP is recalling 47,848 blood and urine collection kits distributed nationwide. The recall involves 17 specific catalog numbers of Medline Convenience Kits. The affected products are sterile applicators that may contain fungal contamination.
The FDA identified that certain lots of these sterile applicators may contain Aspergillus penicillioides, a fungus that can grow under specific environmental conditions. Contamination of skin preparation products with this organism 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 listed in the official recall notice. If the products are found, they should be removed from use and returned to Medline or the distributor for credit or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1
- Manufacturer
- Medline Industries, LP
- Affected units
- 47,848
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) DYNDB3086D
- UDI-DI: 10195327313234(each)
- 40195327313235(case)
- Lot Number: 24IBA685
- 2) DYNDB3100
- UDI-DI: 10198459028915(each)
- 40198459028916(case)
- Lot Number: 24IBF913
- 3) DYNDH1619A
- UDI-DI: 10195327215835(each)
- 40195327215836(case)
- Lot Number: 24FBH708
- 4) DYNDH1619A
- Lot Number: 24HBG622
- 5) DYNDH1620A
- UDI-DI: 10195327216047(each)
- 40195327216048(case)
- Lot Number: 24GBY827
- 6) DYNDH1620A
- Lot Number: 24HBQ593
Distribution
Distributed nationwide across the United States.
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