Palindrome Non-Precision
RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 23 cm
2manufacturers in China registered for this device type
1catalogue number
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) | K111817 |
| Record published | 2014-09-22 |
| Record revised | 2025-12-24 (version 11) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 | Storage environment temperature 15 to 30 °C; Handling environment temperature 59 to 86 °F; Special storage condition: Keep away from sunlight. |
| Packaging | Pack_or_inner_pack of 5 |
| Sizes | Length 23 cm; catheter gauge 15 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888541023 | Length 23 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| 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 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
Recalls Naming This Product
13 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 |
|---|---|---|---|---|---|
| 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). |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
| 2025-04-23 | Class II | Packaging | Potential breach of sterile barrier packaging. | 95,938 units |
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.