Z-2156-2025 Class II Ongoing
FDA device recall Z-2156-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on June 12, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 48 units.
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