Palindrome
Precision HSI Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 28 cm
2manufacturers in China registered for this device type
139catalogue numbers in this listing
5recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Mozarc Medical US LLC, United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K112477 |
| Record published | 2014-09-22 |
| Record revised | 2025-12-10 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Handling environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Packaging | Pack_or_inner_pack of 5 |
| Sizes | Length 19 to 55 cm; catheter gauge 14.5 to 15 Fr |
| Distribution end date | 2021-08-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888145043 | Catheter Gauge 14.5 Fr | In distribution |
| 8888133508 | Catheter Gauge 14.5 Fr | In distribution |
| 8888123409 | Length 23 cm | In distribution |
| 8888541055 | Length 55 cm | In distribution |
| 8888128458P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145039P | Length 19 cm | In distribution |
| 8888145066CP | Length 55 cm | In distribution |
| 8888123410 | Length 23 cm | In distribution |
| 8888541019 | Length 19 cm | In distribution |
| 8888145058 | Length 19 cm | In distribution |
| 8888145042P | Length 33 cm | In distribution |
| 8888145065 | Catheter Gauge 14.5 Fr | In distribution |
| 8888128459P | Length 28 cm | In distribution |
| 8888541028 | Length 28 cm | In distribution |
| 8888128454 | Length 28 cm | In distribution |
| 8888133510P | Catheter Gauge 14.5 Fr | In distribution |
| 8888119369P | Length 19 cm | In distribution |
| 8888123404 | Length 23 cm | In distribution |
| 8888145059 | Length 23 cm | In distribution |
| 8888128459 | Length 28 cm | In distribution |
| 8888145045C | Length 28 cm | In distribution |
| 8888123408 | Catheter Gauge 14.5 Fr | In distribution |
| 8888119364P | Length 19 cm | In distribution |
| 8888145041 | Length 28 cm | In distribution |
| 8888145043C | Catheter Gauge 14.5 Fr | In distribution |
| 8888145062P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145060P | Length 28 cm | In distribution |
| 8888145069 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145064P | Catheter Gauge 14.5 Fr | In distribution |
| 8888123404P | Length 23 cm | In distribution |
| 8888145018P | Length 55 cm | In distribution |
| 8888128458 | Length 28 cm | In distribution |
| 8888145017 | Length 33 cm | In distribution |
| 8888145065P | Catheter Gauge 14.5 Fr | In distribution |
| 8888146144CP | Length 44 cm | In distribution |
| 8888145018 | Length 55 cm | In distribution |
| 8888145057 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145071P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145064 | Catheter Gauge 14.5 Fr | In distribution |
| 8888128454P | Length 28 cm | In distribution |
| 8888145063 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145050 | Catheter Gauge 14.5 Fr | In distribution |
| 8888133500 | Length 33 cm | In distribution |
| 8888133508P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145041P | Length 28 cm | In distribution |
| 8888133510 | Length 33 cm | In distribution |
| 8888145016P | Length 28 cm | In distribution |
| 8888145014 | Length 19 cm | In distribution |
| 8888145057P | Catheter Gauge 14.5 Fr | In distribution |
| 8888133504 | Length 33 cm | In distribution |
| 8888123410P | Length 23 cm | In distribution |
| 8888541044 | Length 44 cm | In distribution |
| 8888145048C | Catheter Gauge 14.5 Fr | In distribution |
| 8888123409P | Length 23 cm | In distribution |
| 8888123400P | Length 23 cm | In distribution |
| 8888145048 | Catheter Gauge 14.5 Fr | In distribution |
| 8888119364 | Length 19 cm | In distribution |
| 8888145040 | Length 23 cm | In distribution |
| 8888145015 | Length 23 cm | In distribution |
| 8888145046 | Length 33 cm | In distribution |
| 8888145048P | Catheter Gauge 14.5 Fr | In distribution |
| 8888123405 | Catheter Gauge 14.5 Fr | In distribution |
| 8888133504P | Length 33 cm | In distribution |
| 8888145068P | Catheter Gauge 14.5 Fr | In distribution |
| 8888119360 | Length 19 cm | In distribution |
| 8888145070P | Catheter Gauge 14.5 Fr | In distribution |
| 8888128461 | Catheter Gauge 14.5 Fr | In distribution |
| 8888133509P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145061P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145058P | Length 19 cm | In distribution |
| 8888145057C | Catheter Gauge 14.5 Fr | In distribution |
| 8888119365 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145061 | Length 33 cm | In distribution |
| 8888128450 | Length 28 cm | In distribution |
| 8888145046C | Length 33 cm | In distribution |
| 8888145050C | Catheter Gauge 14.5 Fr | In distribution |
| 8888145044C | Length 23 cm | In distribution |
| 8888145049P | Length 28 cm | In distribution |
| 8888119371 | Length 19 cm | In distribution |
| 8888146044P | Length 44 cm | In distribution |
| 8888145057CP | Catheter Gauge 14.5 Fr | In distribution |
| 8888133509 | Catheter Gauge 14.5 Fr | In distribution |
| 8888119368P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145016 | Length 28 cm | In distribution |
| 8888145044 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145062C | Length 19 cm | In distribution |
| 8888145040P | Length 23 cm | In distribution |
| 8888541033 | Length 33 cm | In distribution |
| 8888145015P | Length 23 cm | In distribution |
| 8888145063P | Length 23 cm | In distribution |
| 8888145014P | Length 19 cm | In distribution |
| 8888145049C | Length 28 cm | In distribution |
| 8888128460 | Length 28 cm | In distribution |
| 8888119369 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145066 | Catheter Gauge 14.5 Fr | In distribution |
| 8888128460P | Length 28 cm | In distribution |
| 8888128450P | Length 28 cm | In distribution |
| 8888145059P | Length 23 cm | In distribution |
| 8888119368 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145049 | Catheter Gauge 14.5 Fr | In distribution |
| 8888145069P | Length 23 cm | In distribution |
| 8888145050P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145062 | Length 19 cm | In distribution |
| 8888145050CP | Catheter Gauge 14.5 Fr | In distribution |
| 8888145066P | Length 55 cm | In distribution |
| 8888145060 | Length 28 cm | In distribution |
| 8888133500P | Length 33 cm | In distribution |
| 8888123400 | Length 23 cm | In distribution |
| 8888145039 | Length 19 cm | In distribution |
| 8888145070 | Length 28 cm | In distribution |
| 8888119360P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145063C | Length 23 cm | In distribution |
| 8888123408P | Catheter Gauge 14.5 Fr | In distribution |
| 8888145017P | Length 33 cm | In distribution |
| 8888145045 | Length 28 cm | In distribution |
| 8888145048CP | Catheter Gauge 14.5 Fr | In distribution |
| 8888145049CP | Catheter Gauge 14.5 Fr | In distribution |
| 8888119370P | Length 19 cm | In distribution |
| 8888145042 | Length 33 cm | In distribution |
| 8888146144P | Catheter Gauge 14.5 Fr | In distribution |
| 8888541028P | Length 28 cm | Withdrawn |
| 8888145062CP | Length 19 cm | Withdrawn |
| 8888145064C | Length 28 cm | Withdrawn |
| 8888541044P | Length 44 cm | Withdrawn |
| 8888145063CP | Length 23 cm | Withdrawn |
| 8888128455 | Length 28 cm | Withdrawn |
| 8888145066C | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888119370 | Length 19 cm | Withdrawn |
| 8888145068 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888145065C | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888541055P | Length 55 cm | Withdrawn |
| 8888133511 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888145065CP | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888541019P | Length 19 cm | Withdrawn |
| 8888541033P | Length 33 cm | Withdrawn |
| 8888133505 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888145071 | Catheter Gauge 14.5 Fr | Withdrawn |
| 8888541023P | Length 23 cm | Withdrawn |
| 8888145064CP | Length 28 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
| HemoSplit Long-Term Hemodialysis Catheter | Bard Access Systems, Inc. | 35 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
Recalls Naming This Product
76 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mozarc Medical US LLC | 510(k) number | 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units | |
| Mozarc Medical US LLC | 510(k) number | 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units | |
| Mozarc Medical US LLC | 510(k) number | 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units | |
| Mozarc Medical US LLC | 510(k) number | 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units | |
| Mozarc Medical US LLC | 510(k) number | 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units | |
| Covidien | 510(k) number | 2024-03-15 | Class II | Process control | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating | 305 units | |
| Covidien | 510(k) number | 2024-03-15 | Class II | Process control | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating | 878 units | |
| Covidien | 510(k) number | 2023-08-22 | Class II | Under Investigation by firm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body. | 3050 devices | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 213,589 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 26,675 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 2,462 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 25,765 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 576,018 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 26,474 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 2,462 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 13,526 units | |
| Covidien | 510(k) number | 2022-06-08 | Class I | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. | 132,443 units | |
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2021-05-28 | Class II | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | ||
| Covidien | 510(k) number | 2015-04-23 | Class II | Nonconforming Material/Component | Catheters may not meet antimicrobial specification | 72,363 US – 24,631 Internationally | 2017-07-26 |
| Covidien | 510(k) number | 2015-04-23 | Class II | Nonconforming Material/Component | Catheters may not meet antimicrobial specification | 72,363 US – 24,631 Internationally | 2017-07-26 |
| Covidien | 510(k) number | 2015-04-23 | Class II | Nonconforming Material/Component | Catheters may not meet antimicrobial specification | 72,363 US – 24,631 Internationally | 2017-07-26 |
| Covidien | 510(k) number | 2015-04-23 | Class II | Nonconforming Material/Component | Catheters may not meet antimicrobial specification | 72,363 US – 24,631 Internationally | 2017-07-26 |
| Covidien | 510(k) number | 2015-04-23 | Class II | Nonconforming Material/Component | Catheters may not meet antimicrobial specification | 72,363 US – 24,631 Internationally | 2017-07-26 |
Showing 40 of 76.
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.