Vygon Portugal

Activity by year

Devices registered here (2)

• Tubes, Gastrointestinal (And Accessories)
  Product code KNT (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980
• Tube, Feeding
  Product code FPD (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980

Recalls & enforcement

• Class IIOngoing2021-04-15
  Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
• Class IITerminated2018-12-06
  DualStop Caps defect causing leaks in affected product
• Class IITerminated2018-02-28
  Potential friction holes may affect the sterility of the product.
• Class IITerminated2014-08-28
  Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
• Class IITerminated2012-12-17
  Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
• Class IITerminated2012-05-11
  Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

FDA inspections (1)

• VAI2024-04-11
  Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by VYGON S A
• Vygon Verneuil (FR)
• VYGON S A (FR)
• SIPA (FR)
• VYGON Germany GmbH (DE)
• Dimequip (BE)
• VYGON COLOMBIA S.A. (CO)
• SAP (FR)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)