Cortrak 2 Enternal Access Device
CORTRAK* 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet with ENFit® Connector
25manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product code
35recalls on this code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K220588 |
| Record published | 2020-05-15 |
| Record revised | 2023-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 8 to 12 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45797 | Catheter Gauge 10 Fr | In distribution |
| 45818 | Catheter Gauge 10 Fr | In distribution |
| 45823 | Catheter Gauge 8 Fr | In distribution |
| 46093 | Catheter Gauge 8 Fr | In distribution |
| 46100 | Catheter Gauge 8 Fr | In distribution |
| 46047 | Catheter Gauge 10 Fr | In distribution |
| 45809 | Catheter Gauge 8 Fr | In distribution |
| 46051 | Catheter Gauge 8 Fr | In distribution |
| P20-0950 | In distribution | |
| 45791 | Catheter Gauge 8 Fr | In distribution |
| 46098 | Catheter Gauge 10 Fr | In distribution |
| 46053 | Catheter Gauge 10 Fr | In distribution |
| 45802 | Catheter Gauge 12 Fr | In distribution |
| 46094 | Catheter Gauge 10 Fr | In distribution |
| 46049 | Catheter Gauge 12 Fr | In distribution |
| 45782 | Catheter Gauge 10 Fr | In distribution |
| 46044 | Catheter Gauge 8 Fr | In distribution |
| 46055 | Catheter Gauge 8 Fr | In distribution |
| 20-0950 | In distribution | |
| 20-0950 | In distribution | |
| 46089 | Catheter Gauge 10 Fr | In distribution |
| 46041 | Catheter Gauge 10 Fr | In distribution |
| 46097 | Catheter Gauge 8 Fr | In distribution |
| 46090 | Catheter Gauge 12 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241185 | 2024-10-25 |
| K240965 | 2024-06-06 |
| K220588 | 2022-04-22 |
| K191340 | 2019-06-04 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 234 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 54 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 208 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 31 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 218 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 61 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 22 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 1,615 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 901 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 72 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 1,205 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 53 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 1,006 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 3,184 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 231 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 49 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 6,005 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 41 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 43 kits | |
| 2026-04-30 | Class II | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | 132 kits | |
| 2024-05-31 | Class II | Error in labeling | The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. | 53,384 kits | |
| 2024-01-16 | Class I | Nonconforming Material/Component | MIC* Gastric – Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. | 10808 units | |
| 2024-01-16 | Class I | Nonconforming Material/Component | MIC* Gastric – Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. | 53126 Units | |
| 2022-03-21 | Class I | Device Design | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol. | 721 devices | 2024-09-09 |
| 2021-12-22 | Class II | Under Investigation by firm | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | 692 units | 2023-08-15 |
| 2021-12-22 | Class II | Under Investigation by firm | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | 2652 units | 2023-08-15 |
| 2020-10-16 | Class II | Under Investigation by firm | Detachment of the Male AIV Adaptor from the Y-Connector. | 710 units | 2022-09-30 |
| 2020-07-29 | Class II | Under Investigation by firm | Devices had cracked or detached from the feeding tube body | 284 units | 2023-01-31 |
| 2019-10-08 | Class II | Under Investigation by firm | The connector piece to the PEG tube does not pass over the guidewire. | 104 cases (208 units) total | 2022-03-16 |
| 2019-10-08 | Class II | Under Investigation by firm | The connector piece to the PEG tube does not pass over the guidewire. | 104 cases (208 units) total | 2022-03-16 |
| 2018-10-24 | Class III | Under Investigation by firm | The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date | 654 boxes (32700 units) | 2020-09-16 |
| 2017-02-03 | Class II | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. | 2 cases (5 units per case) | 2019-08-05 |
| 2017-02-03 | Class II | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. | 8 cases (2 units per case) | 2019-08-05 |
| 2017-02-03 | Class II | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. | 2 cases (5 units per case) | 2019-08-05 |
| 2012-01-26 | Not classified | Mixed-up of materials/components | The wrong size Twoomey adapter was packaged with the Jejunal tube. | 145 units | 2012-03-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.