Vygon Maximum Barrier Tray Recall: Sterility Risk from Friction Holes

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Vygon is recalling its Maximum Barrier Tray convenience kits for PICC insertions because friction holes could compromise sterility. This poses a risk of infection during medical procedures.

Why it’s dangerous

Friction holes in the tray could create pathways for contaminants, risking infection during PICC insertion procedures. The product is designed for sterile medical use, so any breach in sterility could lead to infections.

Who’s affected

Healthcare professionals using the Maximum Barrier Tray for PICC insertions are most at risk. Patients receiving these procedures may be affected if the product is used without sterility.

How to tell if you have this one

Check for product code AMS-9018CP on the tray. Units sold with lot number 17I024D and UDI 08498840010068 are affected.

Brand
Vygon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product code AMS-9018CP and lot number 17I024D to confirm if your item is affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states potential friction holes may affect sterility, so it is not recommended for use until a remedy is provided.

What should I do if I have this product?

The recall record does not specify a remedy, so contact Vygon directly for guidance.

How can I tell if my product is affected?

Check for product code AMS-9018CP and lot number 17I024D on the tray.

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-1635-2018 — Vygon Vygon

Hello,

I own a Vygon that is covered by recall Z-1635-2018 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-1635-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1635-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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 Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.

Lower-risk recall