Medline recalls two procedure kits with masks that failed bioburden testing per EN 14683 standards. Affected kits include Port Access Kit (CVI5130) and VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE (STCVC01USGV).
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Medline is recalling two specific procedure kits because their masks didn't meet bioburden testing requirements for medical use. This means the masks could have harmful bacteria levels that don't meet international safety standards.
The masks failed bioburden testing, meaning they might contain too many bacteria. This could lead to infections if used in medical procedures where sterility is critical. The issue is specific to the masks in these kits, not the entire product.
Healthcare workers using these kits in medical settings are most at risk. Patients receiving procedures with these kits could be exposed to higher bacterial contamination.
Check for Medline procedure kits labeled as Port Access Kit (reorder CVI5130) or VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE (reorder STCVC01USGV). The kits were sold in the US with specific lot numbers from April to October 2024.
Look for the product names and reorder numbers on the kit packaging to confirm if it's affected.
The masks failed bioburden testing requirements for EN 14683, meaning they might have too many bacteria for medical use.
Port Access Kit (reorder CVI5130) and VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE (reorder STCVC01USGV).
Check the product labels for the specific reorder numbers and lot numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1040-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-1040-2025 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.
