Safe-T-Centesis
Safe-T-Centesis 8Fr Catheter Drainage Kit - Safe-T-Centesis Catheter Drainage Device, Extension Set, Scalpel, Vacuum Needle, and Sharps Engineered Safety Device
1manufacturer
7catalogue 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 15 to 30 °C |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIG1280K | Size = 8 French (F) | In distribution |
| PIG1260TCDF | Size = 6 French (F) | In distribution |
| PIG1280TSP | Size = 8 French (F) | In distribution |
| PIG1260TSP | Size = 6 French (F) | In distribution |
| PIG1260T | Size = 6 French (F) | In distribution |
| PIG1260K | Size = 6 French (F) | In distribution |
| PIG1280T | 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 | Carefusion 2200, Inc. | 5 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 5 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | UDI-DI | 2022-04-22 | Class II | Under Investigation by firm | There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wal | 1460 units | |
| 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 | |
| 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
9 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 |
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.