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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: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (1773)

Page 21 of 36

Device	Model / Reference	Registries	Class	Status
Vygon	1362.047	FDA UDI	Class II	Active
Vygon	516.25	FDA UDI	Class II	Active
Vygon	AMS-539-1	FDA UDI	Class II	Active
Vygon	AMS-7100CS	FDA UDI	Class I	Active
Vygon	AMS-9818CP-4	FDA UDI	Class I	Active
Vygon	1340.18	FDA UDI	Class II	Unknown
Vygon	368.32	FDA UDI	Class II	Active
Vygon	2395.05	FDA UDI	Class II	Unknown
Vygon	AMS-7522CP	FDA UDI	Class I	Active
Vygon	AMS-9540CP	FDA UDI	Class II	Active
Vygon	AMS-638A	FDA UDI	Class II	Active
Vygon	AMS-9868CP-3A	FDA UDI	Class II	Active
Vygon	AMS-615	FDA UDI	Class II	Active
Vygon	AMS-954CP	FDA UDI	Class II	Active
Vygon	391.08	FDA UDI	Class II	Active
Vygon	2394.12	FDA UDI	Class II	Unknown
Vygon	391.06	FDA UDI	Class II	Active
Vygon	5249.721	FDA UDI	Class II	Active
Vygon	311.08	FDA UDI	Class II	Active
Vygon	KS-975-2	FDA UDI	Class II	Active
Premicath	1261.205G	FDA UDI	Class II	Active
Vygon	311.06	FDA UDI	Class II	Active
Vygon	362.142	FDA UDI	Class II	Active
Vygon	896.038 E	FDA UDI	Class II	Active
Vygon	AMS-7160CPA	FDA UDI	Class II	Active
Vygon	5516.35	FDA UDI	Class II	Active
Vygon	AMS-615	FDA UDI	Class II	Active
Vygon	1340.14	FDA UDI	Class II	Unknown
Vygon	220.050	FDA UDI	Class II	Active
Vygon	246.08	FDA UDI	Class II	Active
Vygon	368.02	FDA UDI	Class II	Active
Vygon	VYPL4D3003SK-1	FDA UDI	Class II	Active
Vygon	AMS-7598CP-1	FDA UDI	Class II	Active
Vygon	AMS-8181CP	FDA UDI	Class II	Active
Vygon	AMS-9849-1	FDA UDI	Class I	Active
Vygon	AMS-609-1	FDA UDI	Class II	Active
Vygon	5805.02	FDA UDI	Class I	Active
Vygon	AMS-9959CP-7	FDA UDI	Class II	Active
Lifecath S	2296.304	FDA UDI	Class II	Active
Vygon	VYG45MN-S	FDA UDI	Class II	Active
Vygon	AMS-9288CP	FDA UDI	Class II	Active
Vygon	1015.122M	FDA UDI	Class II	Active
Vygon	SHS-2034	FDA UDI	Class II	Active
Vygon	VYML5D1002	FDA UDI	Class II	Active
Vygon	115.090	FDA UDI	Class II	Active
Vygon	AMS-7074CP-2	FDA UDI	Class II	Active
Vygon	AMS-8526CP-2	FDA UDI	Class II	Active
Vygon	SHY-2034-1	FDA UDI	Class II	Active
Vygon	542.06	FDA UDI	Class I	Active
Vygon	AMS-884-2T	FDA UDI	Class II	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.