Silicone PEG Guidewire System
Catalogue number 010063, listed by Bard Access Systems, Inc., United States, under Tubes, Gastrointestinal (And Accessories). 25 manufacturers in China are registered for this product code.
25manufacturers in China registered for this device type
1catalogue number
40recalls 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 | Bard Access Systems, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2024-04-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12, case of 2 |
| Sizes | Catheter gauge 20 Fr |
| Distribution end date | 2023-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010063 | Catheter Gauge 20 Fr | Withdrawn |
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)
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 808 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1231 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 105 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 2533 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 435 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 114 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 2254 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1922 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 450 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 475 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1046 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 474 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1072 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 7680 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1280 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 221 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 100 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 1516 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 432 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 65 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 5432 units | 2010-05-18 |
| 2008-12-22 | Not classified | Process control | Out of specification replacement gastrostomy device was distributed. | 294 units | 2010-05-18 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retriev | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
| 2008-12-04 | Not classified | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal duri | 177,614 units | 2011-11-09 |
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.