Medline recalls two types of convenience kits due to potential sterility breaches in packaging. If the sterile barrier is compromised, users may face infection risks. Affected kits have specific model numbers and lot numbers.
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.
Medline is recalling two types of convenience kits because their packaging might have wrinkles that compromise sterility. This could lead to infections if the kits are used without a clean seal. The risk is low for most people but higher for those with weakened immune systems.
The packaging for the kits has wrinkles that could extend to the seal area, potentially allowing microbial contamination. If the sterile barrier is broken, users might get infections ranging from minor to severe, especially in vulnerable patients.
Healthcare workers and patients using these kits during labor or delivery are most at risk. Immunocompromised individuals face a higher chance of serious infection.
Check for model numbers CDS981762B (Labor CDS kits) or DYKA1054F (Vaginal Delivery Admission Bags). Lot numbers from 23KBQ478 to 24JBN932 are affected.
Inspect the packaging for wrinkles that might extend to the seal area.
If you find wrinkles in the packaging, discard the kit immediately to avoid infection risk.
The kits may have packaging issues that could compromise sterility. If you see wrinkles in the packaging, discard them immediately. Otherwise, they are safe to use.
Check the model number and lot number on the packaging. If it matches the affected items listed, discard the kits to avoid infection risk.
Yes, but inspect the packaging for wrinkles. If you find any, discard the kit immediately to prevent potential infection.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-3059-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-3059-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
