Vygon PICC Tray Recall: Sterility Risk from Friction Holes

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Recalling firmVygon U.S.A.2750 Morris Rd Ste A200, N/A · Lansdale, PA 19446-6083

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Vygon is recalling a PICC tray kit (product code AMS-909:93CP) because friction holes might affect its sterility. This could lead to infections if the tray isn't properly sterilized. The recall covers specific lot numbers.

Why it’s dangerous

Friction holes in the tray could create small openings that allow contaminants to enter the sterile field during use. This might compromise the sterility of the PICC insertion process, increasing infection risk.

Who’s affected

Patients using PICC (peripherally inserted central catheter) lines with this specific tray kit are most at risk. Healthcare providers who use the product for medical procedures may also be affected.

How to tell if you have this one

Check for the product code AMS-9093CP on the tray. The recall includes lot numbers 16I026D and 16J032D. This kit is sold for inserting PICCs into the vascular system.

Brand
Vygon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 16I026D or 16J032D on the tray packaging.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for potential sterility issues, but the risk is low. Vygon states that friction holes could affect sterility, but no injuries have been reported.

How do I know if I have the recalled product?

Check the product code AMS-9093CP and lot numbers 16I026D or 16J032D on the tray.

What should I do if I have the recalled product?

Vygon does not provide a specific remedy in this recall notice. Contact Vygon directly for further instructions.

Take action

Contact Vygon

We’ve drafted a message you can send Vygon to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1637-2018 — Vygon Vygon

Hello,

I own a Vygon that is covered by recall Z-1637-2018 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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Where this comes from

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.

Official source: FDA Recall #Z-1637-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1637-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Vygon U.S.A. recalls PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Lower-risk recall