Diapact®
CWHD/CWHFD Tubing Set (unassembled)
5manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
14recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | FJK |
| Device type | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-08-09 |
| Record revised | 2024-06-03 (version 7) |
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 | Storage environment temperature 0 to 30 °C |
| Distribution end date | 2024-05-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7210511 | Volume : 7000.000 ML | 24 | In distribution |
| 7210517 | 4 | Withdrawn | |
| 7210518 | 4 | Withdrawn | |
| 7210513 | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 58 |
| Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET | Nipro Medical Corporation | 12 |
| Hemodialysis Bloodlines | B. Braun Medical Inc. | 12 |
| CombiSet | Fresenius Medical Care | 11 |
| Cartridge Blood Set | Gambro Renal Products S.A. DE C.V. | 8 |
| 5008X | Fresenius Medical Care Renal Therapies Group, LLC | 7 |
| Sunder | Sunder Biomedical Tech. Co., Ltd. | 6 |
| Streamline Airless System Set with Locksite Needleless Access Sites | Medisystems Corp. | 5 |
| Tablo(R) Cartridge | Outset Medical, Inc. | 5 |
| NovaLine | Bain Medical Equipment(Guangzhou) Co., Ltd. | 5 |
| Medisystems Hemodialysis Blood Tubing Sets | Medisystems Corp. | 4 |
| Vital | Vital Healthcare SDN. BHD. | 3 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K952631 | 1996-04-30 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 328,640 units |
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 1,174,271 units |
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 4,848 units |
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 4,884 units |
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 2,653,711 units |
| 2026-03-19 | Class I | Device Design | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | 3,158,104 units |
| 2025-09-30 | Class I | Process control | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. | 1298454 units (1589674 – 3/5/26 Expansion) |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 10658351 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 4984920 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 4671540 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 142336 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 11262112 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 9864165 units |
| 2024-08-15 | Class II | Device Design | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inse | 2021376 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.