Vygon Maximum Barrier Insertion 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 a specific medical insertion tray because friction holes could compromise its sterility. This poses a risk of infection during procedures if the tray is used without proper sterility.

Why it’s dangerous

Friction holes in the tray may create pathways for contaminants, potentially breaking the sterile seal. This could lead to infections during medical procedures if the tray is not properly sterilized.

Who’s affected

Healthcare professionals using the tray for PICC insertions are most at risk. Patients receiving procedures with this tray could be affected if sterility is compromised.

How to tell if you have this one

Check for lot numbers 17F001D or 17K038D on the tray. The product code is AMS-9152CP for the Maximum Barrier Insertion Tray.

Brand
Vygon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Look for lot numbers 17F001D or 17K038D on the tray.

✎ 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 the remedy is applied.

What should I do if I have this product?

Check the lot numbers on the tray; if they match 17F001D or 17K038D, contact Vygon for instructions.

How can I confirm if my product is recalled?

Look for lot numbers 17F001D or 17K038D on the tray with product code AMS-9152CP.

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-1636-2018 — Vygon Vygon

Hello,

I own a Vygon that is covered by recall Z-1636-2018 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-1636-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1636-2018 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 Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular

Lower-risk recall