Z-1114-2019Class II

Vygon DUALSTOP Red Cap used for intravascular lines

Name: Z-1114-2019 Vygon DUALSTOP Red Cap used for intravascular lines
Creator: Vygon U.S.A.
Published: 2018-12-06
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2018-12-06 / Terminated / root cause: manufacturing process

FDA source

Vygon U.S.A. began a recall of Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines on 2018-12-06. FDA classified it as Class II and gives the reason as "DualStop Caps defect causing leaks in affected product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1114-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-06
Posted: 2019-04-09
Terminated: 2020-05-12
Recalling firm: Vygon U.S.A.
Product: Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Product code: FPA Set, Administration, Intravascular
Reason for recall: DualStop Caps defect causing leaks in affected product
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Vygon issued recall letter on 12/6/18 via email or fax stating the defect, health risk and action to be taken. Distributors were provided with instructions on how to handle product that was further distributed by them. Contact your local sales representative or Vygons Customer Service Department at 1-800-473-5414, or by e-mail at [email protected]
Quantity in commerce: 339,800
Distribution: US Nationwide distribution.
Product codes and lots: Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1114-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1114-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-09
Z-1115-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-09

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)