Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for potential seal defect
What this means
Medline is recalling Convenience Kits containing BD ChloraPrep Clear 1mL applicators because some units may have an open or incomplete seal on the applicator packaging. This defect could allow contamination, potentially leading to skin, soft tissue, or systemic infection if the applicator is used.
- Check if you have affected lots: CDS983348AA (lots 24IBK346, 24JBK539) or CDS983348AB (lots 25CBF097, 25HBB232, 25HBB761, 25HBH209, 25HBU907, 25JBQ176).
- Do not use applicators with visibly damaged, open, or incomplete seals.
- Contact Medline or your healthcare facility for instructions on replacement or proper disposal.
- Report any infections or injuries to Medline and your healthcare provider.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3068-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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