Medline Convenience Kits recalled for potential sterility breach in BD ChloraPrep applicators
What this means
Two Medline Convenience Kits contain BD ChloraPrep Clear applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the sterile seal is breached, the applicators could be contaminated with microbes, potentially exposing patients and users to infection.
- If you have Drawer 9 Cricothyrotomy Kit (Model ACC010741, Lot 23KDB215) or Anesthesia L&D A-Line Set Kit (Model DYKMBNDL199A, Lots 24LBT847 or 24LBB138), do not use the kits.
- Contact Medline Industries for instructions on returning or replacing the kits.
- Review your records to determine if any of these kits were used, and consult with your healthcare provider if you have concerns.
The agency's original wording
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3048-2026More 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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