Medline blood culture convenience kits recalled for sterility packaging breach
What this means
Medline's blood culture convenience kits contain sterile applicators with a potential packaging defect—wrinkles in the paper lidding may compromise the sterile barrier. If the seal is breached, the applicators could be exposed to microbial contamination, which could potentially cause infection if used.
- Check if you have one of the affected kit models (DYNDH1193 or DYNDH1487A) and lot numbers listed in the recall notice.
- Do not use affected kits; contact Medline or your healthcare facility for guidance on safe alternatives or replacement kits.
- If a patient was already treated using an affected kit, monitor for signs of infection and consult a healthcare provider if symptoms 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-3057-2026More 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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