Flotrac
Flotrac Sensor (84" / 213CM)
1manufacturer
3catalogue numbers in this listing
4510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DQE |
| Device type | Catheter, Oximeter, Fiber-Optic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1230 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K131588 |
| Record published | 2016-09-03 |
| Record revised | 2018-07-06 (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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Packaging | Shipper of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MHD85 | PRESSURE TUBING: 84 IN (213 CM) LENGTH | In distribution |
| MHD8S102 | PRESSURE TUBING: 84 IN (213 CM) LENGTH | In distribution |
| MHD6 | PRESSURE TUBING: 60 IN (152 CM) LENGTH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 65 |
| Vital Signs™ | AirLife Finland Oy | 12 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Edwards Oximetry Central Venous Catheter | Edwards Lifesciences Technology Sarl | 6 |
| Vital Signs | Carefusion Finland 320 Oy | 6 |
| HemoSphere | Edwards Lifesciences Technology Sarl | 5 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 3 |
| HemoSphere Alta | Edwards Lifesciences Technology Sarl | 3 |
| Vigileo | Edwards Lifesciences Technology Sarl | 2 |
| ForeSight IQ | Edwards Lifesciences Technology Sarl | 1 |
| Pediasat | Edwards Lifesciences Technology Sarl | 1 |
| Presep | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 18. All products under Catheter, Oximeter, Fiber-Optic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160645 | 2016-06-16 |
| K110167 | 2011-02-18 |
| K060093 | 2006-04-28 |
| K053609 | 2006-02-28 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 33,327 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 6,714 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 1417 units |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 11,072 units |
Recalls
7 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 | Closed |
|---|---|---|---|---|---|
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 70 UNITS | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 218 UNITS | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 152 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 178 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 50 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 200 UNITS | 2024-01-29 |
| 2020-03-27 | Class II | Under Investigation by firm | Sterile catheter kit packaging compromised. | 597 units | 2021-04-27 |
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.