Schon
14F x 15cm Schon XL Silicone Double Lumen Catheter (Temporary Access)
2manufacturers in China registered for this device type
18catalogue numbers in this listing
4510(k) clearances naming this product code
34recalls 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 | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-15 |
| Record revised | 2021-11-03 (version 6) |
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 |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 5, box of 10 |
| Sizes | Length 14 to 26 cm; needle gauge 18 G; catheter gauge 14 Fr |
| Distribution end date | 2021-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10802304 | Needle Gauge 18 G | In distribution |
| 10800603 | Length 20 cm | In distribution |
| 10802402 | In distribution | |
| 10802401 | In distribution | |
| 10800601 | In distribution | |
| 10802302 | Needle Gauge 18 G | In distribution |
| 10801702 | Length 20 cm | In distribution |
| 10800602 | In distribution | |
| 10802301 | Needle Gauge 18 G | In distribution |
| 10800701 | Needle Gauge 18 G | In distribution |
| 10801701 | Length 15 cm | In distribution |
| 10801805 | Length 20 cm | Withdrawn |
| 10801808 | Length 26 cm | Withdrawn |
| 10801802 | Length 14 cm | Withdrawn |
| 10801804 | Length 18 cm | Withdrawn |
| 10801806 | Length 22 cm | Withdrawn |
| 10801803 | Length 16 cm | Withdrawn |
| 10801807 | Length 24 cm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110936 | 2011-06-10 |
| K101843 | 2010-10-20 |
| K080400 | 2008-05-13 |
| K040402 | 2004-04-19 |
Recalls
15 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 | Closed |
|---|---|---|---|---|---|
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 555 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 188 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 35 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 83 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 15 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 260 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 250 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 157 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 455 units | |
| 2024-03-18 | Class II | Under Investigation by firm | XXX | 285 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 50 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 40 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 30 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 65 units | |
| 2024-03-18 | Class II | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | 50 units | |
| 2011-01-24 | Not classified | Nonconforming Material/Component | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 39 units | 2016-02-02 |
| 2011-01-24 | Not classified | Nonconforming Material/Component | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 537 units | 2016-02-02 |
| 2011-01-24 | Not classified | Nonconforming Material/Component | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 12 units | 2016-02-02 |
| 2011-01-24 | Not classified | Nonconforming Material/Component | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 503 units | 2016-02-02 |
| 2011-01-24 | Not classified | Nonconforming Material/Component | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. | 33 units | 2016-02-02 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 137 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 1,195 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 208 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 40 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 52 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 240 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 675 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 66 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 137 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 26 | 2012-07-25 |
| 2010-01-08 | Not classified | Other | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers | 174 | 2012-07-25 |
| 2008-07-07 | Not classified | Process design | The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site. | 2012-08-02 | |
| 2008-07-07 | Not classified | Process design | The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site. | 2012-08-02 | |
| 2008-07-07 | Not classified | Process design | The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site. | 2012-08-02 |
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.