Device product
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.
Z-2155-2025
Product summary
- Event
- Event 97154
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15700 units
- Official record key
device-enforcement:Z-2155-2025
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Derived failure modes
-
Labeling or packaging
open seal
-
Sterility assurance
seal on its packaging. This may constitute a breach to sterility