MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-2153-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
Product Description:
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Product Classification:
Class II
Date Initiated: June 12, 2025
Date Posted: July 30, 2025
Recall Number: Z-2153-2025
Event ID: 97154
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.
Status: Ongoing
Product Quantity: 960 units
Code Information:
UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566
Distribution Pattern:
Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Voluntary or Mandated:
Voluntary: Firm initiated