Medline Convenience Kits Recalled for 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.
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, 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. The recall is a downstream action following the manufacturer's recall of the specific BD ChloraPrep Clear applicators contained within these kits.
The affected product may exhibit an open or incomplete seal on the packaging of the applicator. The use of a potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. A total of 222,653 units were distributed nationwide in the US.
Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI-DI codes listed in the recall notice. If the product is found, it should be removed from use and returned to Medline or the distributor according to their instructions.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
- Manufacturer
- Medline Industries, LP
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medline Industries, LP
See all →- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Colorectal Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline IV Start Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential ChloraPrep Applicator Contamination
FDA (Devices) · 2026-09-09
Same hazard · infection
See all →- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Arterial Line Insertion Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09