Cardinal Health
Voiding Cysto Urethrogram Tray
11manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FCN |
| Device type | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-08-02 |
| Record revised | 2022-06-10 (version 5) |
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, manufacturing date |
| Packaging | Case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-0370C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 16 |
| Dover | Cardinal Health 200, LLC | 12 |
| Cook | Cook Incorporated | 10 |
| SteriGear | SteriGear, LLC | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Neomed* | Avanos Medical, Inc. | 5 |
| ProCure | Twin Med, LLC | 4 |
| Surgyco | Surgyco LLC | 3 |
| Neil Medical Group | Neil Medical Group | 3 |
| LSL Healthcare | Lsl Industries, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| BioFlo | Insert Molding Solutions, Inc. | 1 |
Showing 12 of 17. All products under Urinary Drainage Collection Kit, For Indwelling Catheter
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-12-04 | Class I | Nonconforming Material/Component | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. | 195600 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.