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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 4 of 36

Device	Model / Reference	Registries	Class	Status
Vygon	SHS-2234	FDA UDI	Class II	Active
Vygon	AMS-934-1	FDA UDI	Class II	Active
Vygon	AMS-9538CP	FDA UDI	Class II	Active
Vygon	AMS-426-1	FDA UDI	Class II	Active
Vygon	1261.20N	FDA UDI	Class II	Active
Vygon	AMS-9192CP	FDA UDI	Class II	Active
Vygon	CLG-2234	FDA UDI	Class II	Active
Vygon	AMS-9275CP-2	FDA UDI	Class I	Active
Vygon	1015.352	FDA UDI	Class II	Active
Vygon	AMS-9021CP-1A	FDA UDI	Class II	Active
Vygon	310.05	FDA UDI	Class II	Unknown
Vygon	AMS-8405CP-3	FDA UDI	Class I	Active
Vygon	AMS-8502CP-1	FDA UDI	Class I	Active
Vygon	AMS-9377CP-2	FDA UDI	Class II	Active
Vygon	340.14	FDA UDI	Class II	Unknown
Vygon	AMS-500NS	FDA UDI	Class II	Active
Vygon	AMS-7192CS-8	FDA UDI	Class II	Active
Vygon	AMS-8502CP	FDA UDI	Class I	Active
Vygon	AMS-9059CP	FDA UDI	Class II	Active
Vygon	AMS-9008-1	FDA UDI	Class II	Active
Vygon	310.10	FDA UDI	Class II	Active
Vygon	CLG-1934	FDA UDI	Class II	Active
Vygon	AMS-9377CP-1	FDA UDI	Class II	Active
Vygon	AMS-9294CS	FDA UDI	Class II	Active
Vygon	KS-122-2	FDA UDI	Class II	Active
Vygon	CLGY-2210	FDA UDI	Class II	Active
Vygon	AMS-9008-2	FDA UDI	Class II	Active
Vygon	246.09	FDA UDI	Class II	Active
Vygon	VYML4S1003	FDA UDI	Class II	Active
Vygon	AMS-9377CP-2	FDA UDI	Class II	Active
Vygon	340.08	FDA UDI	Class II	Unknown
Vygon	1363.082	FDA UDI	Class II	Active
Vygon	1311.04	FDA UDI	Class II	Unknown
Vygon	310.04	FDA UDI	Class II	Unknown
Vygon	AMS-638A	FDA UDI	Class II	Active
Vygon	CMS-814-1	FDA UDI	Class II	Active
Vygon	MBS-2015	FDA UDI	Class II	Active
Vygon	AMS-761	FDA UDI	Class II	Active
Vygon	AMS-427	FDA UDI	Class II	Active
Vygon	1362.1221	FDA UDI	Class II	Active
Vygon	AMS-903-1MNV	FDA UDI	Class II	Active
Vygon	AMS-9012CP	FDA UDI	Class I	Active
Vygon	AMS-7200	FDA UDI	Class I	Active
Vygon	AMS-9316CP-4B	FDA UDI	Class I	Active
Vygon	AMS-436	FDA UDI	Class II	Active
Vygon	391.18	FDA UDI	Class II	Active
Vygon	AMS-290	FDA UDI	Class II	Active
Vygon	SHY-2010	FDA UDI	Class II	Active
Vygon	AMS-385	FDA UDI	Class II	Active
Vygon	AMS-8167	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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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.