Vygon Corp.
Montgomeryville, PA, US
Vygon Corp. appears in FDA device records in Montgomeryville, PA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 12 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Vygon Corp. between 2011 and 2012. The busiest year on record is 2011, with 1. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 |
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Data as of , FDA export datePage updated Source: openFDA, public domain