B.braun
Transfer Set - 26 Lines
2manufacturers in China registered for this device type
1catalogue number
3recalls on this code
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | NEP |
| Device type | System/Device, Pharmacy Compounding |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2020-03-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2112550 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exactamix | Baxter Healthcare Corporation | 27 |
| ICU Medical, Inc. | ICU Medical, Inc | 16 |
| Apex™ | B. Braun Medical Inc. | 15 |
| Pinnacle® | B. Braun Medical Inc. | 13 |
| System/Device, Pharmacy Compounding | Baxter Healthcare Corporation | 9 |
| DianaTM Compounding Workflow System | ICU Medical, Inc | 9 |
| Repeater | Baxter Healthcare Corporation | 8 |
| DianaTM Automated Drug Compounding System | ICU Medical, Inc | 5 |
| Single Lead High Volume Pump Chamber SET | MPS Pharma & Medical, Inc. | 4 |
| Abacus | Baxter Healthcare Corporation | 4 |
| Apoteca | AEA SRL | 3 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
Showing 12 of 35. All products under System/Device, Pharmacy Compounding
Recalls
3 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 |
|---|---|---|---|---|---|
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 248 units | 2023-03-14 |
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 16 units | 2023-03-14 |
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 85 units | 2023-03-14 |
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.