Medline Convenience Kits recalled for potential sterility breach in ChloraPrep applicators
What this means
Several Medline Convenience Kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkled paper packaging that may compromise the sterile barrier. If the packaging is breached, the applicators could be exposed to microbial contamination, which could lead to localized or serious infection in patients.
- Check if you have one of the affected kits by matching your catalog number and lot number to the FDA recall list
- Stop using affected kits and quarantine them
- Contact Medline or your healthcare provider for instructions on replacement or safe disposal
- Monitor patients who may have used these kits 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-3049-2026More 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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