Medline Convenience Kits: 1) OPEN HEART ADULT recall: Contamination
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST…
Why was Medline Convenience Kits: 1) OPEN HEART ADULT recalled?
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBJ654; 2) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24FBM444; 3) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24HBJ581; 4) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24HBT102
- Product
- Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST…
- Recalling firm
- Medline Industries, LP
- Quantity
- 489 kits
- Distribution
- US Nationwide distribution.
- Recall date
- September 23, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)