Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
What this means
Medline's Arterial Line Insertion Kit (Model ART1295) contains sterilization applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, patients could be exposed to microbial contamination, ranging from no effect to serious infection.
- Check if you have Medline Arterial Line Insertion Kit Model ART1295 with lot numbers 2024092790, 2025042590, or 2025070290.
- Do not use affected kits; contact your supplier or Medline for replacement or return instructions.
- Review procedures performed with potentially affected kits and monitor patients for signs of infection.
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-3055-2026More 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 Convenience Kits with BD ChloraPrep Clear applicators recalled for potential contamination
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