Medline Convenience Kits Recalled for Potential Fungal Contamination
Medline is recalling 489 convenience kits nationwide because they may contain sterile applicators contaminated with Aspergillus penicillioides, which can cause 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 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 489 convenience kits distributed nationwide. The affected products are the Open Heart Adult (Catalog Number CDS840396Y), Full Line Aneurysm CDS (Catalog Number CDS983672O), and Non Sterile Chest Tube Removal (Catalog Number DYNDA1080) kits. Specific lot numbers are 24FBJ654, 24FBM444, 24HBJ581, and 24HBT102.
The recall is due to the presence of certain lots of sterile applicators that may contain fungal contamination. Under specific environmental conditions, this contamination allows for the growth of Aspergillus penicillioides. The FDA classifies this as a Class I recall because contamination of skin preparation products with this fungus may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should check their inventory for the specific catalog numbers and lot numbers listed above. If you have used these products and are experiencing symptoms of infection, contact your healthcare provider.
The recalled product
- Product
- Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 489
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 (14)
- 1) CDS840396Y
- UDI-DI: 10195327574932(each)
- 40195327574933(case)
- Lot Number: 24FBJ654
- 2) CDS983672O
- UDI-DI: 10195327207625(each)
- 40195327207626(case)
- Lot Number: 24FBM444
- 3) CDS983672O
- Lot Number: 24HBJ581
- 4) DYNDA1080
- UDI-DI: 10884389388679(each)
- 40884389388670(case)
- Lot Number: 24HBT102
Distribution
Distributed nationwide across the United States.
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