Z-2156-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
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 Pattern
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Code Information
UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761