Medline recalls ART1295 Arterial Line Insertion Kits with potential sterility breaches due to packaging wrinkles. Affected kits may risk infection or hospitalization if sterile barrier is compromised.
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 its ART1295 Arterial Line Insertion Kits because the packaging may have wrinkles that compromise sterility. This could lead to infections or hospitalization if the kit is used without a fully sterile barrier.
The kits' packaging may develop wrinkles that extend to the seal area, potentially breaching sterility. If the sterile barrier is compromised, users could be exposed to microbial contamination, leading to infections ranging from mild to severe requiring hospitalization.
Healthcare professionals and patients using arterial line insertion kits. Those with weakened immune systems or critical conditions face higher infection risks.
Check for Model Number ART1295 with Lot Numbers 2024092790, 2025042590, or 2025070290. These kits were sold with specific UDI-DI codes and packaging.
Inspect the packaging for wrinkles that may extend to the seal area, indicating potential sterility breach.
If wrinkles are present, discard the kit immediately to avoid potential contamination.
The recalled kits have Model Number ART1295.
Lot Numbers 2024092790, 2025042590, and 2025070290 are affected.
Yes, but if you find wrinkles, discard the kit immediately to avoid potential contamination.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-3055-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-3055-2026 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.
