Cardinal Health
Trumpet Valve w/ Cassette 5mm x 33cm Composite Probe Single Spike
24manufacturers in China registered for this device type
109catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | GBX |
| Device type | Catheter, Irrigation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-27 |
| Record revised | 2026-06-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 8, case of 12, case of 10, box of 6, case of 2 |
| Distribution end date | 2025-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SU130-1311 | In distribution | |
| SU130-1308 | In distribution | |
| JP-HUR100 | In distribution | |
| CT-HU1910 | In distribution | |
| JP-2228 | In distribution | |
| SU130-1310 | In distribution | |
| SU130-1321 | In distribution | |
| ASC1200 | In distribution | |
| JP-HUF104 | In distribution | |
| JP-2234 | In distribution | |
| JP-HUR101 | In distribution | |
| SU130-1410 | In distribution | |
| JP-HUF100 | In distribution | |
| SU130-1320 | In distribution | |
| JP-HUR150 | In distribution | |
| SU130-1411 | In distribution | |
| JP-HUR870 | In distribution | |
| JP-2229 | In distribution | |
| ASC1210 | In distribution | |
| SU130-1323 | In distribution | |
| JP-HUR101 | In distribution | |
| ABP1201 | In distribution | |
| JP-HUF104 | In distribution | |
| SU130-0325 | In distribution | |
| SU130-1311 | In distribution | |
| SU130-1309 | In distribution | |
| SU130-1321 | In distribution | |
| SU130-1310 | In distribution | |
| SU130-1525 | In distribution | |
| JP-HUF070 | In distribution | |
| JP-HUR150 | In distribution | |
| 30416-058 | In distribution | |
| JP-HUR151 | In distribution | |
| JP-HUR890 | In distribution | |
| SU130-0521 | In distribution | |
| JP-2230 | In distribution | |
| SU130-1308 | In distribution | |
| ASC1211 | In distribution | |
| CT-HU1910 | In distribution | |
| JP-HUR910 | In distribution | |
| JP-HUF071 | In distribution | |
| SU130-1309 | In distribution | |
| JP-2226 | In distribution | |
| SU130-0323 | In distribution | |
| CT-HU1900 | In distribution | |
| SU130-401D | In distribution | |
| JP-HUR151 | In distribution | |
| SU130-0321 | In distribution | |
| SU130-1410 | In distribution | |
| JP-HUF071 | In distribution | |
| JP-HUR100 | In distribution | |
| JP-HUF070 | In distribution | |
| JP-2227 | In distribution | |
| JP-2231 | In distribution | |
| JP-HUR195 | In distribution | |
| SU130-1525 | In distribution | |
| SU130-1320 | In distribution | |
| SU130-0321 | In distribution | |
| SU130-0525 | In distribution | |
| SU130-0320 | In distribution | |
| ASC1221 | In distribution | |
| JP-HUR860 | In distribution | |
| SU130-1334 | In distribution | |
| SU130-1411 | In distribution | |
| SU130-1325 | In distribution | |
| SU130-0523 | In distribution | |
| JP-HUF100 | In distribution | |
| JP-HUR880 | In distribution | |
| JP-HUR900 | In distribution | |
| 30414-058 | In distribution | |
| JP-HUR880 | In distribution | |
| SU130-1325 | In distribution | |
| JP-HUF101 | In distribution | |
| SU130-0521 | In distribution | |
| JP-HUR190 | In distribution | |
| SU130-1323 | In distribution | |
| ASC1201 | In distribution | |
| ASC1220 | In distribution | |
| JP-2213 | In distribution | |
| JP-HUR860 | Withdrawn | |
| SU130-401D | Withdrawn | |
| SU130-0325 | Withdrawn | |
| JP-2227 | Withdrawn | |
| JP-2234 | Withdrawn | |
| JP-HUR870 | Withdrawn | |
| JP-HUR900 | Withdrawn | |
| JP-2226 | Withdrawn | |
| SU130-0525 | Withdrawn | |
| JP-2228 | Withdrawn | |
| SU130-1334 | Withdrawn | |
| JP-2231 | Withdrawn | |
| ASU1200 | Withdrawn | |
| JP-HUR190 | Withdrawn | |
| JP-2229 | Withdrawn | |
| ASU1210 | Withdrawn | |
| SU130-0523 | Withdrawn | |
| ASU1211 | Withdrawn | |
| JP-HUF101 | Withdrawn | |
| JP-HUR195 | Withdrawn | |
| ASU1201 | Withdrawn | |
| JP-2230 | Withdrawn | |
| JP-2213 | Withdrawn | |
| SU130-0323 | Withdrawn | |
| CT-HU1900 | Withdrawn | |
| ASU1220 | Withdrawn | |
| JP-HUR910 | Withdrawn | |
| SU130-0320 | Withdrawn | |
| JP-HUR890 | Withdrawn | |
| ASU1221 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| One-Step™ | Merit Medical Systems, Inc. | 167 |
| Cook | Cook Incorporated | 85 |
| ReSolve® | Merit Medical Systems, Inc. | 68 |
| Pleur-Evac | Teleflex Medical LLC | 66 |
| Jackson-Pratt | Cardinal Health 200, LLC | 47 |
| Total Abscession | AngioDynamics, Inc. | 36 |
| Channel Drain | C.R. Bard, Inc. | 36 |
| ReSolve Mini™ | Merit Medical Systems, Inc. | 32 |
| Silicone Tubing, Radiopaque | Bentec Medical OpCo, LLC. | 25 |
| Blake | Ethicon, Inc. | 19 |
| Silicone Tubing, Translucent | Bentec Medical OpCo, LLC. | 19 |
| Thoracentesis and Paracentesis Set | Merit Medical Systems, Inc. | 17 |
Showing 12 of 223. All products under Catheter, Irrigation
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 202 cases of 12 |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 220 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 2277 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 7129 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 15493 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 24963 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 29515 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 8563 units |
| Cardinal Health 200, LLC | UDI-DI | 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 22847 units |
Recalls
31 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 |
|---|---|---|---|---|---|
| 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 2905 cases of 12 | |
| 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 128 cases of 12 | |
| 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 64 cases of 6 | |
| 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 98 cases of 12 | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 0 | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 1768 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 892 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 5680 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 3520 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 0 | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 1150 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 0 | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 3550 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 4372 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 179 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 2259 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 1920 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 750 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 921 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 3507 | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 812 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 2480 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 4112 units | |
| 2022-12-14 | Class II | Unknown/Undetermined by firm | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of | 4111 devices | |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
| 2018-06-11 | Class II | Device Design | The suction valve may not close properly which could cause continuous suction. | A total of 63,020 valves were distributed. Specific product | 2020-08-17 |
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.