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Open, Classified

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P

FDA Recall Z-2154-2025 · Posted 2025-07-21

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRS
Date Initiated2025-06-12
Product Quantity184 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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