System/Device, Pharmacy Compounding
Vented Solution Transfer Set, Large Bore Tubing and Two Spike Connectors
2manufacturers in China registered for this device type
9catalogue numbers in this listing
8recalls 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 | Baxter Healthcare Corporation, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-07-21 (version 9) |
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 |
| Packaging | Case of 48 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1C8592 | In distribution | ||
| 2C0430 | In distribution | ||
| 1C8189 | In distribution | ||
| 1C8624 | In distribution | ||
| 2C0415 | In distribution | ||
| 2B8045 | 1,000 | Withdrawn | |
| 2C0426 | Withdrawn | ||
| 2C0463 | Withdrawn | ||
| 2B8044 | 1,000 | Withdrawn |
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 |
| 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 |
| Exactamix | Baxter Corporation Englewood | 3 |
Showing 12 of 35. All products under System/Device, Pharmacy Compounding
Recalls
5 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 | Closed |
|---|---|---|---|---|---|
| 2026-04-22 | Class II | Under Investigation by firm | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue ma | 105675 | |
| 2022-06-22 | Class I | Software design | There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. | 9 units | 2024-10-09 |
| 2015-11-30 | Class II | Under Investigation by firm | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. | 77,136 units | 2016-10-30 |
| 2013-11-08 | Class II | Nonconforming Material/Component | Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA fi | 28 devices | 2015-03-23 |
| 2012-07-13 | Class I | Device Design | After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also, the AUTOMIX system may experience an intermittent ele | 950 units | 2017-08-11 |
| 2012-07-13 | Class I | Device Design | After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also, the AUTOMIX system may experience an intermittent ele | 3106 units | 2017-08-11 |
| 2012-07-13 | Class I | Device Design | After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also, the AUTOMIX system may experience an intermittent ele | 270 units | 2017-08-11 |
| 2012-07-13 | Class I | Device Design | After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also, the AUTOMIX system may experience an intermittent ele | 840 units | 2017-08-11 |
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.