Vygon recalls Neonatal PICC Tray (Product Code AMS-801:1) due to potential friction holes affecting sterility. This could lead to infections during medical procedures.
Potential friction holes may affect the sterility of the product.
Vygon is recalling a neonatal PICC tray (Product Code AMS-8010CP-1) because friction holes might compromise sterility, increasing infection risk during infant IV procedures.
Friction holes in the tray could create small openings that allow contaminants to enter, potentially breaking the sterile field during critical medical procedures.
Healthcare providers using neonatal PICC trays for infant IV lines. Infants receiving PICC insertions are most at risk.
Check for Product Code AMS-8010CP-1 on the tray. The lot number 17C060D and UDI 08498840010563 are associated with this recall.
Look for Product Code AMS-8010CP-1 on the neonatal PICC tray.
The recall is due to potential friction holes that could compromise sterility during infant IV procedures.
Check for Product Code AMS-8010CP-1 on the tray, with Lot Number 17C060D and UDI 08498840010563.
The recall does not specify a remedy, so contact Vygon for further instructions.
We’ve drafted a message you can send Vygon to request your refund or repair — edit it as you like.
Subject: Recall Z-1634-2018 — Vygon Vygon Hello, I own a Vygon that is covered by recall Z-1634-2018 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.
