Vygon recalls Maximum Barrier Tray (Product Code MCITX-1) due to potential friction holes risking sterility. Affected lot numbers: 16I025D, 16L026D, 17C014D. No remedy specified.
Potential friction holes may affect the sterility of the product.
Vygon is recalling its Maximum Barrier Tray (Product Code MCITX-1) because friction holes could compromise sterility. This is a serious risk for medical procedures requiring sterile environments.
Friction holes in the tray could create small openings that allow contaminants to enter, potentially breaking the sterile seal needed for medical procedures. This risk is specific to the tray's use in vascular access procedures.
Healthcare professionals using this tray for PICC insertions are most at risk. Patients receiving PICC procedures with this product may be affected.
Check for Product Code MCITX-1 on the tray. Affected lot numbers are 16I025D, 16L026D, and 17C014D. The tray is used for inserting PICCs into the vascular system.
Look for Product Code MCITX-1 on the tray to confirm it's affected.
The recall record does not specify any remedy.
Lot numbers 16I025D, 16L026D, and 17C014D are affected.
Check for Product Code MCITX-1 and lot numbers 16I025D, 16L026D, or 17C014D.
We’ve drafted a message you can send Vygon to request your refund or repair — edit it as you like.
Subject: Recall Z-1638-2018 — Vygon Vygon Hello, I own a Vygon that is covered by recall Z-1638-2018 from Vygon. 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.
