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Vygon Corp.

Last updated May 23, 2026

What Vygon Corp. makes

The company manufactures intravenous administration tubing extension sets, nasogastric feeding tubes, and vascular catheterization support/maintenance kits for non-medicated use. It also produces vascular catheter introduction sets (nonimplantable), vascular port administration sets, and peripheral intravenous catheterization support kits. Single-use ENFit oral/enteral syringes and peripherally-inserted central venous catheters are part of its portfolio.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (1773)

Page 33 of 36

Device	Model / Reference	Registries	Class	Status
Vygon	AMS-8182	FDA UDI	Class II	Active
Vygon	AMS-7639CP	FDA UDI	Class I	Active
Vygon	310.10	FDA UDI	Class II	Unknown
Vygon	AMS-497-1	FDA UDI	Class II	Active
Vygon	1310.04	FDA UDI	Class II	Active
Vygon	AMS-9067CP	FDA UDI	Class I	Active
Vygon	AMS-7072CS	FDA UDI	Class II	Active
Vygon	AMS-879	FDA UDI	Class II	Active
Vygon	38.07.05	FDA UDI	Class II	Active
Vygon	1340.12	FDA UDI	Class II	Unknown
Vygon	1155.03	FDA UDI	Class II	Active
Vygon	VAT3005	FDA UDI	Class II	Active
Vygon	5804.08	FDA UDI	Class I	Active
Vygon	36.45.20	FDA UDI	Class II	Active
Vygon	1362.1271	FDA UDI	Class II	Active
Vygon	AMS-823CP	FDA UDI	Class II	Active
Vygon	876.20	FDA UDI	Class II	Active
Vygon	AMS-440	FDA UDI	Class II	Active
Vygon	1364.082	FDA UDI	Class II	Active
Vygon	1340.06	FDA UDI	Class II	Unknown
Vygon	AMS-912CP-2	FDA UDI	Class II	Active
Vygon	AMS-441	FDA UDI	Class II	Active
Vygon	876.20	FDA UDI	Class II	Active
Vygon	CLGY-2015	FDA UDI	Class II	Active
Vygon	AMS-240	FDA UDI	Class II	Active
Vygon	366.087	FDA UDI	Class II	Active
Vygon	VAMST3.5	FDA UDI	Class II	Active
Vygon	AMS-904	FDA UDI	Class II	Active
Vygon	SHY-2015	FDA UDI	Class II	Active
Vygon	310.07	FDA UDI	Class II	Unknown
Vygon	390.16	FDA UDI	Class II	Active
Nutriline	1252.030G	FDA UDI	Class II	Active
Vygon	AMS-8198CS	FDA UDI	Class II	Active
Vygon	BN-308	FDA UDI	Class II	Active
Vygon	520.45	FDA UDI	Class II	Active
Vygon	AMS-887-4	FDA UDI	Class II	Active
Vygon	181.05	FDA UDI	Class II	Active
Vygon	VY-NEOMAX	FDA UDI	Class II	Active
Vygon	270.06	FDA UDI	Class II	Active
Vygon	368.102	FDA UDI	Class II	Unknown
Vygon	364.052	FDA UDI	Class II	Unknown
Vygon	AMS-926CPS	FDA UDI	Class II	Active
Vygon	310.06	FDA UDI	Class II	Unknown
Vygon	AMS-934-1	FDA UDI	Class II	Active
Vygon	AMS-122-1	FDA UDI	Class II	Active
Vygon	AMS-905CS-1	FDA UDI	Class II	Active
Vygon	246.06	FDA UDI	Class II	Active
Vygon	AMS-467C	FDA UDI	Class II	Active
Vygon	VYML3S1001	FDA UDI	Class II	Active
Vygon	CLG-2210	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (23)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Vygon Corp. has 23 recall records initiated between April 9, 2003, and August 28, 2014, all of which are recorded as terminated. The recalls involved issues such as potential problems with membrane elasticity in the Bionector Needleless connector, incorrect packaging of catheter sheath sizes, mislabeled introducer needles, guidewire malfunctions, and potential bacterial contamination in skin-prep wipes. Reasons also included voluntary manufacturer recalls of heparin lock flush syringes and kits, as well as concerns about catheter hub integrity and leakage.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Aug 28, 2014	Z-0113-2015	—	terminated	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.
Dec 17, 2012	Z-0937-2013	—	terminated	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.
May 11, 2012	Z-1798-2012	—	terminated	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.
May 11, 2012	Z-1806-2012	—	terminated	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.
May 11, 2012	Z-1801-2012	—	terminated	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.
May 11, 2012	Z-1808-2012	—	terminated	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.
May 11, 2012	Z-1807-2012	—	terminated	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.
May 11, 2012	Z-1800-2012	—	terminated	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.
May 11, 2012	Z-1805-2012	—	terminated	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.
May 11, 2012	Z-1797-2012	—	terminated	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.
May 11, 2012	Z-1804-2012	—	terminated	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.
May 11, 2012	Z-1803-2012	—	terminated	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.
May 11, 2012	Z-1799-2012	—	terminated	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.
May 11, 2012	Z-1802-2012	—	terminated	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.
Apr 26, 2011	Z-2700-2011	—	terminated	Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
Apr 26, 2011	Z-2699-2011	—	terminated	Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
Apr 19, 2011	Z-2391-2011	—	terminated	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Apr 19, 2011	Z-2389-2011	—	terminated	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Apr 19, 2011	Z-2390-2011	—	terminated	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Apr 19, 2011	Z-2388-2011	—	terminated	Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Jun 27, 2005	Z-0090-06	—	terminated	Guidewire protuding from tip of the catheter
Apr 9, 2003	Z-0849-03	—	terminated	Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
Apr 9, 2003	Z-0850-03	—	terminated	Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.