Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects
Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could lead to infection.
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 injury has not yet been reported, specifically the potential for localized or systemic infection due to packaging defects.
Plain-English summary
Medline Industries, LP is recalling specific lots of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators (PAIN PRE OP KIT, DYKS1476A). The recall affects 222,653 units distributed nationwide in the United States. This is a downstream recall initiated because the manufacturer of the BD ChloraPrep Clear applicators recalled specific lots due to quality issues.
The affected product may exhibit an open or incomplete seal on the packaging of the applicator. The use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Healthcare providers and consumers should stop using the affected product immediately. The specific lots involved are 25IBJ918, 25KBN677, 25LBU066, and 26BBD775, associated with UDI-DI 10198459362835.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Prep
- 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 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775
Distribution
Distributed nationwide across the United States.
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