Medline IVS Blood Culture Kits recalled for potential sterility breach
What this means
Medline's IVS Blood Culture Kits (models DYNDH1920 and DYNDH1920A) contain sterile applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, the applicators could be exposed to microbial contamination before use.
- Check if you have one of the affected kits (lot numbers 2023111390, 2023121890, or 2025022790).
- Do not use kits with wrinkled or damaged packaging.
- Contact Medline or your supplier for instructions on replacement or return.
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-3051-2026More 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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