Vygon Mfg
Dover, NH, US
Vygon MFG appears in FDA device records in Dover, NH. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 45 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Vygon Mfg 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.
- Churchill Medical Systems, Inc.510(k), enforcement report, recall
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Vygon Mfg between 1988 and 2004. The busiest year on record is 2002, with 4. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 2001 | 3 |
| 2002 | 4 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | KPE | Substantially Equivalent | |
| K021395 | MODIFICATION TO 30 EXTENSION SET | FPA | Substantially Equivalent | |
| K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | Substantially Equivalent | |
| K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA | FPA | Substantially Equivalent | |
| K013950 | VENTED VIAL ACCESS DEVICE | FPA | Substantially Equivalent | |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | FMG | Substantially Equivalent | |
| K011888 | PRESSURE ACTIVATED CHECK VALVE | FPA | Substantially Equivalent | |
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | FPA | Substantially Equivalent | |
| K896333 | CMS IV FILTERS | FPB | Substantially Equivalent | |
| K894954 | .22 & 1.2 MICRON IV FILTERS | FPB | Substantially Equivalent | |
| K884370 | CMS IV EXTENSION SETS | FPK | Substantially Equivalent | |
| K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1223004 | 1000120555 | Vygon MFG | 87 Venture Dr, DOVER, NH 03820 US | 2026 | and 25 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
- BSYCatheters, Suction, Tracheobronchial
- OHGCircumcision Tray
- KPEContainer, I.V.
- KMKDevice, Intravascular Catheter Securement
- 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
- PXBPercutaneous Introducer Kit
- OWLPeripheral Catheter Insertion Kit
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- OKEPort Introducer Kit
- JOKScissors, Medical, Disposable
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- OFTSpinal Epidural Anesthesia Kit
- FMGStopcock, I.V. Set
- OVNSuture Kit
- MCZSuture Removal Kit
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
- FPKTubing, Fluid Delivery
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 45| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0585-2020 | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray. | Class II | Terminated | |
| Z-0933-2018 | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency. | The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled. | Class II | Terminated | |
| Z-0682-2018 | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. | Class II | Terminated | |
| Z-0681-2018 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. | Class II | Terminated | |
| Z-0680-2018 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. | Class II | Terminated | |
| Z-0679-2018 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. | Class II | Terminated | |
| Z-0678-2018 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. | Class II | Terminated | |
| Z-1484-2017 | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids. | Incorrect priming volume printed on the device package. | Class II | Terminated | |
| Z-0787-2017 | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids. | Incorrect priming volume is printed on the device package. | Class II | Terminated | |
| Z-1478-2015 | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1477-2015 | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1476-2015 | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1475-2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1474-2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1473-2015 | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1472-2015 | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1471-2015 | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1470-2015 | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1469-2015 | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1468-2015 | Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-1467-2015 | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Terminated | |
| Z-0813-2014 | AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set. | Defective component may cause extension sets to leak. | Class II | Terminated | |
| Z-2252-2013 | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***" | Microbore tubing disconnecting from male luers on the extension sets. | Class II | Terminated | |
| Z-2251-2013 | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. | Microbore tubing disconnecting from male luers on the extension sets. | Class II | Terminated | |
| Z-0914-2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports. | The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain