Is this your brand? Sign in to claim ownership.

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: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (1773)

Page 20 of 36

Device	Model / Reference	Registries	Class	Status
Vygon	AMS-9868CP-3	FDA UDI	Class II	Active
Vygon	CLG-1910	FDA UDI	Class II	Active
Vygon	BN-448	FDA UDI	Class II	Active
Vygon	VYCIS006	FDA UDI	Class II	Active
Vygon	AMS-7328SF	FDA UDI	Class II	Active
Vygon	AMS-9067CP	FDA UDI	Class I	Active
Vygon	1155.15	FDA UDI	Class II	Active
Vygon	CLGY-1910	FDA UDI	Class II	Active
Vygon	VYML4S1001	FDA UDI	Class II	Active
Vygon	340.08	FDA UDI	Class II	Active
Vygon	1015.202M	FDA UDI	Class II	Active
Vygon	AMS-7074CP-2A	FDA UDI	Class II	Active
Vygon	VYLFN1004	FDA UDI	Class II	Active
Vygon	1261.205A	FDA UDI	Class II	Active
Vygon	AMS-747	FDA UDI	Class II	Active
Vygon	AMS-7870CP-21	FDA UDI	Class I	Active
Vygon	AMS-9868CP-3A	FDA UDI	Class II	Active
Vygon	1361.062	FDA UDI	Class II	Active
Vygon	AMS-9046CP-1	FDA UDI	Class II	Active
Vygon	AMS-8180-3CP	FDA UDI	Class II	Active
Vygon	AMS-577-2	FDA UDI	Class II	Active
Vygon	AMS-729CP-3	FDA UDI	Class I	Active
Vygon	820.28	FDA UDI	Class I	Active
Vygon	AMS-9788CP-4	FDA UDI	Class II	Active
Vygon	2395.06	FDA UDI	Class II	Unknown
Vygon	SHY-2034	FDA UDI	Class II	Active
Vygon	SHS-2210-1	FDA UDI	Class II	Active
Vygon	AMS-8465CS	FDA UDI	Class I	Active
Vygon	AMS-9082-1	FDA UDI	Class II	Active
Vygon	2395.05	FDA UDI	Class II	Active
Vygon	VYML4S3001SK-1	FDA UDI	Class II	Active
Vygon	1015.122M-NS	FDA UDI	Class II	Active
Vygon	AMS-9275CP-2	FDA UDI	Class I	Active
Vygon	AMS-8405CP-3	FDA UDI	Class I	Active
Vygon	AMS-8502CP-2	FDA UDI	Class I	Active
Vygon	AMS-520	FDA UDI	Class II	Active
Vygon	AMS-435CV-1	FDA UDI	Class II	Active
Vygon	AMS-483	FDA UDI	Class II	Active
Vygon	312.04	FDA UDI	Class II	Active
Vygon	369.152	FDA UDI	Class II	Active
Vygon	1261.203A	FDA UDI	Class II	Active
Vygon	879.00	FDA UDI	Class II	Active
Vygon	AMS-9788CP-1	FDA UDI	Class I	Active
Vygon	BN-160	FDA UDI	Class II	Active
Vygon	AMS-9540CP	FDA UDI	Class II	Active
Vygon	1015.602M	FDA UDI	Class II	Active
Vygon	AMS-635CV-1	FDA UDI	Class II	Active
Vygon	1022.012	FDA UDI	Class II	Active
Vygon	AMS-9837CP-7	FDA UDI	Class II	Active
Vygon	362.162	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.