Safe-T
Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
1manufacturer
5catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | PXI |
| Device type | Thoracentesis Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-18 |
| Record revised | 2026-05-29 (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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TPT1005SP | Size = 5 French (F) | In distribution |
| TPT1005SDF | Size = 5 French (F) | In distribution |
| OTP5000SP | Size = 5 French (F) | In distribution |
| TPT1000SP | Size = 8 French (F) | In distribution |
| TPT1000SDF | Size = 8 French (F) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 29 |
| Thoracentesis Tray | Carefusion 2200, Inc. | 8 |
| Thoracentesis and Paracentesis Set | Merit Medical Systems, Inc. | 7 |
| Safe-T-Centesis | Carefusion 2200, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 5 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | UDI-DI | 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| Carefusion 2200, Inc. | UDI-DI | 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| Carefusion 2200, Inc. | UDI-DI | 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| Carefusion 2200, Inc. | UDI-DI | 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
Recalls
10 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 | Closed |
|---|---|---|---|---|
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
| 2020-05-28 | Class II | Under Investigation by firm | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. | 2024-09-20 |
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.