SwabSleeve™
Catalogue number SCXT3-5-2000, listed by ICU Medical, Inc, United States, under Cap, Device Disinfectant. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
1recall
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | QBP |
| Device type | Cap, Device Disinfectant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130975 |
| Record published | 2024-04-05 |
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 | Pack of 8, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SCXT3-5-2000 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DualCap® | Merit Medical Systems, Inc. | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| SwabCap™ | ICU Medical, Inc | 2 |
| BD PureHub | Becton, Dickinson AND Company | 2 |
| SwabTip™ | ICU Medical, Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252006 | 2026-03-27 |
| K190918 | 2020-03-06 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2025-06-16 | Class II | Process control | SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced le | 1,427,100 eaches |
| ICU Medical, Inc | 510(k) number | 2025-06-03 | Class II | Process control | Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequ | 1,445,600 |
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.