Medline Convenience Kits Recalled Due to Potential Packaging Seal Defects
Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that may allow contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where potential contamination could lead to infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling specific lots of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators (C-SECTION PREP, DYNJ32702B). The recall involves 222,653 units distributed nationwide in the United States. The affected product may exhibit an open or incomplete seal on the packaging of the applicator.
The recall is being conducted because the use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. This is a downstream recall initiated by the manufacturer of the BD ChloraPrep Clear applicators.
Healthcare facilities and consumers should stop using the affected product immediately. The specific lots involved are 25BBB005, 25GBY063, 25KBI862, 25LBT688, and 26CBG211, associated with UDI-DI 10193489431070. Users should contact Medline Industries, LP for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Prep
- Hazard
- Affected units
- 222,653
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 (1)
- UDI-DI 10193489431070 Lots 25BBB005 25GBY063 25KBI862 25LBT688 26CBG211
Distribution
Distributed nationwide across the United States.
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