Medline Convenience Kits with BD ChloraPrep applicators recalled for open packaging seal risk
What this means
Medline Convenience Kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. Specific lots across four kit models (CDS860014Q, DYKM1000B, CDS860014P, DYNDV2684) are affected. If a compromised applicator is used, it could introduce contamination and lead to skin, soft tissue, or systemic infection.
- Check if you have one of the affected kits or lot numbers listed in the recall notice.
- Do not use applicators from affected lots; contact your healthcare facility or supplier for replacement kits.
- Report any infections or adverse effects related to use of these kits to your healthcare provider or Medline.
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-3071-2026More 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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