Lower risk Medical device recall · FDA · Published December 6, 2018

Vygon DUALSTOP Red Cap Recall: Leaks in Intravascular Line Caps

Vygon recalls DUALSTOP Red Caps for intravascular lines due to leaks. Product code 9888.00 with specific lot codes. Affected users should check their caps and contact Vygon for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1114-2019Medical device Vygon ›

Lower-risk recall

DualStop Caps defect causing leaks in affected product

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69375-vygon-dualstop-red-cap-recall-leaks-in-intravascular-line-caps.

Source Summary by GovInfoNow · govinfonow.com/recall/69375-vygon-dualstop-red-cap-recall-leaks-in-intravascular-line-caps · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1114-2019

Cite this page

“Vygon DUALSTOP Red Cap Recall: Leaks in Intravascular Line Caps.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69375-vygon-dualstop-red-cap-recall-leaks-in-intravascular-line-caps. Based on FDA recall #Z-1114-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2019%22&limit=1).

Vygon U.S.A. voluntarily recalled Vygon DUALSTOP Red Caps for intravascular lines due to a defect causing leaks, the FDA announced on Dec. 6, 2018. The recall affects product code 9888.00 distributed nationwide.

How to tell if you have it

Brand: Vygon
Product: Vygon DUALSTOP Red Cap
Product Code: 9888.00
Lot codes: 310518FD, 050618FD, 140318FD, 160617FD, 200917FD, 061117FD, 090118FD, 200218FD, 290318FD, 110418FD
Units affected: 339,800

The hazard

The DualStop Caps have a defect that causes leaks in the affected product. The FDA record does not report specific incidents or injuries associated with this hazard.

Context

GovInfoNow's records show Vygon U.S.A. has two other recalls on record since Feb. 28, 2018. On April 15, 2021, the company recalled a Dressing Kit due to infection risk from compromised sterile barriers. On Feb. 28, 2018, Vygon recalled a Neonatal PICC Tray over potential sterility risks from friction holes. Other recent recalls of similar products include Medline Dialysis Kits Recall: Silicone Seal Issues May Cause Blood Product Leakage (Jan. 8, 2026) and Medtronic EOPA Arterial Cannula Recall: Pinhole leaks risk serious injury during surgery (June 24, 2026).

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

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1114-2019	Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.; Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD	339,800
Z-1115-2019	Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.; Lot codes: 090718FD 250118FD 081117FD 130218FD 050418FD 020518FD	107700

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.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Dec 6, 2018Firm started the recall
Apr 9, 2019FDA classified it Class II
Apr 17, 2019Published in FDA’s Enforcement Report
May 12, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

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.

Similar recalls

Latest medical device recalls

Keep exploring

More Vygon recalls

Link to this recall

<a href="https://govinfonow.com/recall/69375-vygon-dualstop-red-cap-recall-leaks-in-intravascular-line-caps">Vygon DUALSTOP Red Cap Recall: Leaks in Intravascular Line Caps (GovInfoNow)</a>

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.