Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects
Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators because packaging seals may be open or incomplete, posing a risk of infection.
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, and the hazard involves potential systemic infection, which aligns with the High severity criteria for medical devices.
Plain-English summary
Medline Industries, LP is recalling 222,653 units of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. This is a downstream recall initiated because the manufacturer of the applicators recalled specific lots due to packaging defects.
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 lots 24IBK346, 24JBK539, 25CBF097, 25HBB232, 25HBB761, 25HBH209, 25HBU907, and 25JBQ176. The product was distributed nationwide in the United States. Users should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
- 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)
- CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539
Distribution
Distributed nationwide across the United States.
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