Hospira
3000 mL Empty Container with Attached Y-Transfer Set, Convertible Pins
7manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
| Beijing L&Z Medical Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | KPE |
| Device type | Container, I.V. |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5025 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2025-10-17 (version 6) |
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 |
| Storage | Special storage condition: Room Temperature. Avoid Excessive Heat. Protect from Freezing |
| Packaging | Case of 8, case of 24, case of 200 |
| Sizes | Total volume 100 to 3000 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 792720 | Total Volume 3000 ml | In distribution | |
| 792721 | Total Volume 1000 ml | In distribution | |
| 795123 | Total Volume 100 ml | In distribution | |
| 795112 | Total Volume 250 ml | 6 | In distribution |
| 795113 | Total Volume 500 ml | 6 | In distribution |
| 795119 | Total Volume 1000 ml | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ChemoPlus | Cardinal Health | 54 |
| Secure® | Metrix Company, THE | 46 |
| EVA TPN Bags | Valmed SRL | 45 |
| ChemoPlus | Cardinal Health 200, LLC | 44 |
| Container, I.V. | Metrix Company, THE | 27 |
| EcoFLX™ Empty Mixing Container | Douglas Medical Products, Inc | 22 |
| Cormix | Metrix Company, THE | 21 |
| PiSA BioPharm | Pisa Biopharm Inc. | 20 |
| Pinnacle® | B. Braun Medical Inc. | 20 |
| Apex® | B. Braun Medical Inc. | 18 |
| Acta Medical | Acta Medical, LLC | 17 |
| McKesson | Mckesson Medical-Surgical Inc. | 14 |
Showing 12 of 59. All products under Container, I.V.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251980 | 2026-03-20 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-08-28 | Class II | Material/Component Contamination | Embedded iron oxide glass defect which may have the potential to break off into the solution. | 191,094 units | 2013-09-18 |
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.