Stradis Medical, LLC.
CAP Dressing Change KIT
7manufacturers in China registered for this device type
4catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Zibo Qichuang Medical Products Co., Ltd. | Zibo | Shandong | Manufacturer | 27 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Xiamen ANK Hygiene Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 11 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | LRS |
| Device type | I.V. Start Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Record published | 2018-02-19 |
| Record revised | 2023-01-24 (version 4) |
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 |
| Packaging | Outer box of 50, outer box of 30 |
| Distribution end date | 2023-01-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCT222CK-3A | In distribution | |
| HCT2121CP-1 | In distribution | |
| HCT222CK-3 | In distribution | |
| RS-IV16186N | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,066 |
| Centurion | Centurion Medical Products Corporation | 886 |
| Medline Industries, Inc. | Medline Industries, Inc. | 740 |
| Medline | Medline Industries, Inc. | 621 |
| Medical Action Industries | Medical Action Industries, Inc. | 512 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| Motion Medical Distributing | Haslam Medical, Inc. | 118 |
| LSL Healthcare | Lsl Industries, Inc. | 83 |
| Vygon | Vygon Corp. | 76 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 63 |
| MediChoice | Owens & Minor Distribution, Inc. | 46 |
| McKesson | Mckesson Medical-Surgical Inc. | 21 |
Showing 12 of 58. All products under I.V. Start Kit
Recalls
4 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 |
|---|---|---|---|---|
| 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 600 units |
| 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 250 units |
| 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 275 units |
| 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 1,175 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.