Accessory Equipment, Cardiopulmonary Bypass
Fixed Tray FOR Additional Storage (Sprinter Cart XL)
1manufacturer
15catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-02-19 |
| Record revised | 2018-04-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Depth 740 to 840 mm; height 1080 to 1116 mm; width 580 to 628 mm |
| Distribution end date | 2024-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPRINTER CART XL | Depth 840 mm | In distribution |
| Holder for Oxygenator | In distribution | |
| Conv.kit | In distribution | |
| FIXED TRAY FOR ADDITIONAL STORAGE | In distribution | |
| INFUSION POLE | In distribution | |
| FIXED TRAY FOR ADDITIONAL STORAGE (XL) | In distribution | |
| GAS BOTTLE HOLDER | In distribution | |
| TOP SHELF FOR ROTAFLOW CONSOLE | In distribution | |
| SECOND HANDLE | In distribution | |
| SECOND HANDLE (XL) | In distribution | |
| SPRINTER CART | Height 1080 mm | In distribution |
| TOP SHELF FOR ROTAFLOW CONSOLE (XL) | Withdrawn | |
| Holder f. VKMO 10000/11000/30000/31000 | Withdrawn | |
| Holder for VHK | Connection size 1/4 Inch | Withdrawn |
| Basic holder for VKMO premium holder | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bracket | LivaNova USA, Inc. | 16 |
| VivaCart | CardioQuip | 14 |
| Capiox | Terumo Corp. | 12 |
| CentriMag™ | Thoratec Corp. | 11 |
| LifeSPARC | Cardiacassist, Inc. | 9 |
| Quantum | Spectrum Medical Ltd | 8 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 8 |
| Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 6 |
| Novatemp | Novamed-USA | 5 |
| Inspire | Sorin Group Italia SRL | 5 |
| Holder | Eurosets SRL | 4 |
| Forceps | LivaNova USA, Inc. | 4 |
Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Cardiovascular Us Sales, Llc | UDI-DI | 2020-06-18 | Class II | Under Investigation by firm | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended. | 50 units | 2022-12-30 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2025-06-27 | Class II | Under Investigation by firm | Device does not comply with the labeling requirements of international standard IEC 60601-1. | 7,754 units | |
| 2018-04-04 | Class II | Device Design | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. | 14 units (1 US, 13 International) | 2019-03-29 |
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.