Class 2 Device Recall Medline

• Date Initiated by Firm: June 12, 2025
• Date Posted: July 21, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2153-2025
• Recall Event ID: 97154
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
• Code Information: UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned.
• Quantity in Commerce: 960 units
• Distribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.