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Sign in to claim this brandVygon Corp.
US
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
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (1773)
Page 32 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vygon | AMS-9152CP-1 | FDA UDI | Class II | Active |
| Vygon | AMS-603 | FDA UDI | Class II | Active |
| Vygon | KS-222-2 | FDA UDI | Class II | Active |
| Vygon | SHY-2234 | FDA UDI | Class II | Active |
| Vygon | AMS-391 | FDA UDI | Class II | Active |
| Vygon | 1362.042 | FDA UDI | Class II | Active |
| Vygon | 5562.413 | FDA UDI | Class II | Active |
| Vygon | 368.1571 | FDA UDI | Class II | Active |
| Vygon | 340.21 | FDA UDI | Class II | Active |
| Vygon | 361.042 | FDA UDI | Class II | Active |
| Hct | HCT222CK-V | FDA UDI | Class I | Active |
| Vygon | SS-426 | FDA UDI | Class II | Active |
| Vygon | 1363.0621 | FDA UDI | Class II | Active |
| Nutriline | 1252.30G | FDA UDI | Class II | Active |
| Vygon | 390.10 | FDA UDI | Class II | Unknown |
| Vygon | 1159.20 | FDA UDI | Class II | Active |
| Vygon | MSY-2210 | FDA UDI | Class II | Active |
| Vygon | VAT6007 | FDA UDI | Class II | Active |
| Vygon | 312.10 | FDA UDI | Class II | Active |
| Vygon | 2394.10 | FDA UDI | Class II | Unknown |
| Vygon | VYCIS005 | FDA UDI | Class II | Active |
| Vygon | 362.127 | FDA UDI | Class II | Active |
| Vygon | BN-448 | FDA UDI | Class II | Active |
| Vygon | MBS-2210 | FDA UDI | Class II | Active |
| Vygon | AMS-645CP-1 | FDA UDI | Class II | Active |
| Vygon | 5382.10 | FDA UDI | Class II | Active |
| Vygon | AMS-9028CP-1 | FDA UDI | Class II | Active |
| Vygon | 1310.06 | FDA UDI | Class II | Active |
| Vygon | AMS-300 | FDA UDI | Class II | Active |
| Vygon | 1015.002 | FDA UDI | Class II | Active |
| Vygon | 1362.1621 | FDA UDI | Class II | Active |
| Vygon | 363.062 | FDA UDI | Class II | Active |
| Vygon | CLG-2015 | FDA UDI | Class II | Active |
| Vygon | AMS-6981-1 | FDA UDI | Class II | Active |
| Vygon | 340.16 | FDA UDI | Class II | Unknown |
| Nutriline | 1252.35G | FDA UDI | Class II | Active |
| Premicath | 1261.20G | FDA UDI | Class II | Active |
| Vygon | 368.152 | FDA UDI | Class II | Unknown |
| Vygon | 1361.067 | FDA UDI | Class II | Active |
| Vygon | 362.102 | FDA UDI | Class II | Active |
| Vygon | VYML3S3001 | FDA UDI | Class II | Active |
| Vygon | MSY-1915 | FDA UDI | Class II | Active |
| Vygon | 310.10 | FDA UDI | Class II | Unknown |
| Vygon | 1362.102 | FDA UDI | Class II | Active |
| Vygon | 1362.0821 | FDA UDI | Class II | Active |
| Vygon | AMS-626TGSLF | FDA UDI | Class II | Active |
| Vygon | 368.032 | FDA UDI | Class II | Unknown |
| Vygon | AMS-8165CP-3 | FDA UDI | Class II | Active |
| Vygon | BN-2082CV | FDA UDI | Class II | Active |
| Vygon | SS-885-2 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
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. |