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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
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- US
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Catalogue (1773)
Page 35 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vygon | 363.087 | FDA UDI | Class II | Active |
| Vygon | AMS-300 | FDA UDI | Class II | Active |
| Vygon | SHS-2010 | FDA UDI | Class II | Active |
| Vygon | AMS-2000 | FDA UDI | Class II | Active |
| Vygon | AMS-477 | FDA UDI | Class II | Active |
| Vygon | VYPL5D1003 | FDA UDI | Class II | Active |
| Vygon | 361.062 | FDA UDI | Class II | Unknown |
| Vygon | AMS-975NF | FDA UDI | Class II | Active |
| Vygon | 1155.70 | FDA UDI | Class II | Active |
| Vygon | AMS-427-NS | FDA UDI | Class II | Active |
| Vygon | 115.090 | FDA UDI | Class II | Active |
| Vygon | AMS-9240CP-3 | FDA UDI | Class II | Active |
| Vygon | AMS-9161CPA | FDA UDI | Class II | Active |
| Vygon | AMS-8526CP-2 | FDA UDI | Class II | Active |
| Vygon | 391.12 | FDA UDI | Class II | Active |
| Vygon | AMS-200 | FDA UDI | Class II | Active |
| Vygon | 1270.05 | FDA UDI | Class II | Active |
| Vygon | AMS-290NS | FDA UDI | Class II | Active |
| Health Care Technology | HCT5525PX-V | FDA UDI | Class II | Active |
| Churchill Medical Systems | BHY-2234 | FDA UDI | Class II | Active |
| Boussignac C.p.a.p. Device | K013884 | FDA 510(k) | Class II | Active |
| Vygon Balloon For Identification Of Epidural 193 | K851479 | FDA 510(k) | Class II | Active |
| Bionector | K941678 | FDA 510(k) | Class II | Active |
| Xro Umbilical Catheter-Code 270 | K851005 | FDA 510(k) | Class II | Active |
| Vygon Delee Suction Catheter Code No 533 | K851473 | FDA 510(k) | Class I | Active |
| Modification To: Latex-Free Bionector, Model# 896.019, 896.039 | K070705 | FDA 510(k) | Class II | Active |
| Vygon Guedel Airway 511 Vygon Bermann/Orophar Airw | K851480 | FDA 510(k) | Class II | Active |
| Vygon Lifecath-Picc (pur) Catheters (single And Double Lumen 3fr, 4fr, 4.5fr, And 5fr) | K993442 | FDA 510(k) | Class II | Active |
| Nutrisafe 2- ENFit Adaptor | K151237 | FDA 510(k) | Class II | Active |
| Vygon Double Lumen Picc-Catheters (4fr. And 5fr.) | K983544 | FDA 510(k) | Class II | Active |
| Vygon Spinal Anesthesia Tray Code No. 190 | K851474 | FDA 510(k) | Class I | Active |
| Nutrisafe Pur Enteral Feeding Tube | K003311 | FDA 510(k) | Class II | Active |
| Vygon Nutriline Catheters | K051690 | FDA 510(k) | Class II | Active |
| Vygon Xro Venous/Arterial Umbilical Catheter | K921374 | FDA 510(k) | Class II | Active |
| Vygon Double Lumen Endotracheal Tube | K960795 | FDA 510(k) | Class II | Active |
| Leaderflex | K141026 | FDA 510(k) | Class II | Active |
| Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 And 6502.70/75/80 | K040657 | FDA 510(k) | Class II | Active |
| Multicath Expert | K061250 | FDA 510(k) | Class II | Active |
| Xro Gastro-Duodenal, Dual Flow Tube, Salem Type | K860285 | FDA 510(k) | Class II | Active |
| Vygon Premi-Cath - Long Term Catheter | K954302 | FDA 510(k) | Class II | Active |
| Vygon Umbilical Cathether Insertion Tray | K963196 | FDA 510(k) | Class II | Active |
| Vygon Lifevac Mid-Line Tray | K954112 | FDA 510(k) | Class II | Active |
| Vygon Neo-Sump | K974806 | FDA 510(k) | Class II | Active |
| Vygon Micro-Access Safety Introducer Kit | K051248 | FDA 510(k) | Class II | Active |
| Lectrospiral | K883612 | FDA 510(k) | Class II | Active |
| Hepatostat Set, Model 760x | K061796 | FDA 510(k) | Class II | Active |
| pilot TLS | K241587 | FDA 510(k) | Class II | Active |
| Vygon Exchange Transfusion Tray 275.00 | K851477 | FDA 510(k) | Class II | Active |
| Nutrisafe 2 | K060944 | FDA 510(k) | Class II | Active |
| Mucaid With Suction Catheter And Extension Tubing | K910908 | FDA 510(k) | Class I | Active |
Related Companies
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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. |