Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
This recall is currently active, issued July 21, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 12, 2025
- Posted
- July 21, 2025
- Recall Number
- Z-2156-2025
- Quantity
- 48 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Distribution
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Lot / Code Info
UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761
Root Cause
Other
Action Taken
On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned.