Vygon DUALSTOP Red Cap Recall: Leaks in Intravascular Line Caps

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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 DUALSTOP Red Caps used for intravascular lines because they can leak. This defect could lead to complications in medical procedures if the caps fail to seal properly.

Why it’s dangerous

The caps have a defect that causes leaks during use. This can compromise the integrity of intravascular lines, potentially leading to infections or other complications if the line is not properly sealed.

Who’s affected

Healthcare professionals using intravascular lines and patients receiving such treatments are likely affected. Those with the specific product codes and lot numbers listed are at risk.

How to tell if you have this one

Check for the product code 9888.00 on the cap. Look for lot codes: 310518FD, 050618FD, 140318FD, 160617FD, 200917FD, 061117FD, 090118FD, 200218FD, 290318FD, or 110418FD.

Brand
Vygon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cap Details
Look for the product code 9888.00 and lot codes listed in the recall notice.

✎ GovInfoNow

Questions people ask

Why is this cap being recalled?

The caps have a defect causing leaks in intravascular lines, which could lead to complications during medical procedures.

What should I do if I have this cap?

Check the product code and lot numbers. If you have the affected codes, contact Vygon for further instructions.

Are there any safety risks?

The leak risk is low and does not cause serious injury in normal use, so the danger level is low risk.

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-1114-2019 — Vygon Vygon

Hello,

I own a Vygon that is covered by recall Z-1114-2019 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-1114-2019 (December 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1114-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular

Lower-risk recall