Medline Convenience Kits recalled for sterility breach risk in antiseptic applicators
What this means
Medline Convenience Kits containing BD ChloraPrep Clear and FREPP Clear applicators may have packaging defects—wrinkles in the paper lid that could compromise the sterile barrier. If the packaging is compromised, the sterile applicators inside could be exposed to microbial contamination before use.
- Check your Medline Convenience Kit against the affected lot numbers listed in the FDA notice.
- Do not use affected kits. Contact your healthcare facility or Medline for instructions on return or disposal.
- If you have already used an affected kit, monitor the application site for signs of infection (redness, swelling, warmth, discharge) and report any concerns to your healthcare provider.
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-3050-2026More 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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