Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
- Recall Initiated
- June 12, 2025
- Posted
- July 21, 2025
- Recall Number
- Z-2155-2025
- Quantity
- 15700 units
- Firm Location
- Northfield, IL
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
1) REF DYNDH1462B: UDI/DI 10195327662462 (EA), 40195327662463 (CASE), Lot Numbers: 24EBU164, 24FBD281, 24FBK195; 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA), 40195327509874 (CASE), Lot Numbers: 24EBU004; 3) REF DYNDH1866: UDI/DI 10195327400958 (EA), 40195327400959 (CASE), Lot Numbers: 24EBT285.
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.