Medline Convenience Kits colorectal preparation recalled for sterility packaging breach risk
What this means
Medline Convenience Kits (Model DYNJ906437D) containing BD ChloraPrep and FREPP applicators have wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is breached, patients could be exposed to microbial contamination.
- Check if you have one of the affected lot numbers: 23LBL348, 24BBA259, 24BBN513, 24BBS350, or 24BBU576.
- Do not use kits with these lot numbers.
- Contact your supplier or Medline for instructions on returning or disposing of the affected kits.
- If a patient received a product from one of these lots, consult with a healthcare provider if any signs of infection develop.
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-3052-2026More 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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