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Open, Classified

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D

FDA Recall Z-3075-2026 · Posted 2026-08-31

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeNSB
Date Initiated2026-07-20
Product Quantity222,653 total

Reason for Recall

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Firm Action

Firm began notifying consignees on 7/20/2026 via First-Class Mail and email. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

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

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