Medline Ortho Aspiration Kits Recalled for Potential Contamination
Medline is recalling Ortho Aspiration Kits containing BD ChloraPrep applicators due to packaging seal defects that may allow contamination.
What this means for you
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, consistent with the High severity criteria for potential infection risks.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators, specifically the Ortho Aspiration Kit (DYKM1636A). This is a downstream recall initiated because the manufacturer of the BD ChloraPrep 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.
The recall covers products distributed nationwide in the United States. The specific lot number is 26EBI940 and the UDI-DI is 10889942925858. Users should stop using the affected kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- 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 10889942925858 Lot 26EBI940
Distribution
Distributed nationwide across the United States.
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