Vygon recalls PICC insertion trays with product code AMS-7192CS-3 due to potential friction holes that could compromise sterility. Affected units include specific lot numbers and UDI.
Potential friction holes may affect the sterility of the product.
Vygon is recalling a PICC insertion tray convenience kit because friction holes might affect the product's sterility. This could lead to infections if the tray isn't properly sterile during medical procedures.
Friction holes in the tray could create small openings that might compromise the sterile packaging. This could allow contamination during medical procedures, increasing infection risk.
Healthcare professionals using the tray for PICC insertions are most at risk. Patients receiving PICC treatments may be affected if the tray is used without proper sterility.
Check for product code AMS-7192CS-3 on the tray. Affected units include specific lot numbers listed in the recall notice and have a unique device identifier (UDI) of 08498840009765.
Look for the product code AMS-7192CS-3 and the listed lot numbers on the tray.
The recall addresses a potential risk to sterility, but the remedy is not stated in the record, so the actual danger level is low risk.
The recall record does not specify a remedy, so no action is required based on the information provided.
Check for product code AMS-7192CS-3 and the listed lot numbers or UDI 08498840009765 on the tray.
We’ve drafted a message you can send Vygon to request your refund or repair — edit it as you like.
Subject: Recall Z-1639-2018 — Vygon Vygon Hello, I own a Vygon that is covered by recall Z-1639-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
