Device product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Z-2156-2025
Product summary
- Event
- Event 97154
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-2156-2025
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: UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761
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