Medline Convenience Kits recalled for potential sterility breach in ChloraPrep and FREPP applicators
What this means
Medline's Labor CDS and Vaginal Delivery Admission Bag kits contain ChloraPrep and FREPP applicators with wrinkled packaging that may compromise the sterile barrier. If the seal is breached, patients and healthcare workers may be exposed to microbial contamination, ranging from no injury to serious infection requiring treatment.
- Check if your facility has received affected kits (see lot numbers in the original notice).
- Do not use affected kits; quarantine and return them to Medline.
- Contact Medline or the FDA MedWatch program if kits were already used in patient care.
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-3059-2026More 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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