Vygon U.S.A.
Lansdale, PA, US
VYGON USA appears in FDA device records in Lansdale, PA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 34 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Vygon U.S.A. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vygon Corporationrecall
510(k) clearance history
FDA records hold 4 510(k) clearances for Vygon U.S.A. between 2018 and 2024. The busiest year on record is 2018, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243361 | Nutrifit | FPD | Substantially Equivalent | |
| K212370 | Leaderflex Mini and Leaderflex Nano | FOZ | Substantially Equivalent | |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | PND | Substantially Equivalent | |
| K172899 | Vygon PICCs | LJS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2245270 | 2245270 | VYGON USA | 2750 Morris Rd Suite A200, Lansdale, PA 19446 US | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBTArterial Blood Sampling Kit
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- PXOBone Marrow Biopsy Tray
- OFCCatheter Introducer Kit
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- OXQDressing Change Tray
- FPBFilter, Infusion Line
- LRSI.V. Start Kit
- OJAIntravenous Extension Tubing Set
- DYBIntroducer, Catheter
- KDDKit, Surgical Instrument, Disposable
- PNDMidline Catheter
- FMINeedle, Hypodermic, Single Lumen
- OGJNerve Block Tray
- OFKPercutaneous Atrial Catheter Kit
- OWLPeripheral Catheter Insertion Kit
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- OKEPort Introducer Kit
- JOKScissors, Medical, Disposable
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FMGStopcock, I.V. Set
- OVNSuture Kit
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
- FPKTubing, Fluid Delivery
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 34| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1689-2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection | Class II | Open, Classified | |
| Z-1115-2019 | Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines. | DualStop Caps defect causing leaks in affected product | Class II | Terminated | |
| Z-1114-2019 | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. | DualStop Caps defect causing leaks in affected product | Class II | Terminated | |
| Z-1640-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1639-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1638-2018 | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1637-2018 | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1636-2018 | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1635-2018 | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1634-2018 | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-1633-2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | Class II | Terminated | |
| Z-0113-2015 | Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation. | 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. | Class II | Terminated | |
| Z-0937-2013 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. | 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. | Class II | Terminated | |
| Z-1808-2012 | Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1807-2012 | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1806-2012 | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1805-2012 | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1804-2012 | Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1803-2012 | Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1802-2012 | Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1801-2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1800-2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1799-2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1798-2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated | |
| Z-1797-2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens | 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. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Vygon U.S.A. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain