Medline-Microtek
BAG Decanter II
7manufacturers in China registered for this device type
3catalogue numbers in this listing
5recalls on this code
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 | Microtek Medical LLC, 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, Manufacturer |
| 510(k) | K811269 |
| Record published | 2025-10-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
|---|---|---|---|
| Decanters | 100 | In distribution | |
| Decanters | 100 | In distribution | |
| Decanters | 100 | 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.
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Microtek Medical LLC | 510(k) number | 2024-06-03 | Class II | Device Design | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. | 10,366 cases (518,300 units) |
| Microtek Medical LLC | 510(k) number | 2024-06-03 | Class II | Device Design | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. | 135,999 cases (6,799,950 units) |
| Microtek Medical LLC | 510(k) number | 2024-06-03 | Class II | Device Design | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. | 30,435 cases (1,521,750 units) |
Recalls
2 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 |
|---|---|---|---|---|
| 2024-06-03 | Class II | Device Design | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. | 11,781 cases (589,050 units) |
| 2024-06-03 | Class II | Device Design | During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. | 163 cases (8,150 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.