FDAJune 12, 2026
Medline Convenience Kits Recall Over Sterility Breach in ChloraPrep Applicators
FDA published this notice on June 12, 2026 for United States.
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What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- June 12, 2026
- Recall class
- Class II
- Reason given by the agency
- 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.
- Distribution
- US Nationwide distribution.
- Official source
- the notice at its source
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Source: FDA.