Haemonetics Corporation
Medical device manufacturer in Boston, MA.
36510(k) clearances
0PMA approvals
37recalls
Device types
- CAC Apparatus, Autotransfusion 18
- JPA System, Multipurpose For In Vitro… 5
- KSR Container, Empty, For Collection &… 3
- FPA Set, Administration, Intravascular 2
- FRN Pump, Infusion 2
- BTA Pump, Portable, Aspiration (Manual Or… 2
- GAA Needle, Aspiration And Injection, Disposable 1
- CAL Laryngoscope, Non-Rigid 1
- LKN Separator, Automated, Blood Cell And… 1
- CAK Microfilter, Blood Transfusion 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | 03/29/2024SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | 11/15/2022SE |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA · Traditional | 05/09/2019SE |
| K160502 | TEG 6s Hemostasis SystemJPA · Special | 04/19/2017SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | 01/03/2017SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 05/24/2016SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | 10/25/2012SE |
| K120586 | Cell Saver EliteCAC · Traditional | 05/22/2012SE |
| K101907 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 12/03/2010SE |
| K062801 | Smartsuction Solo DeviceBTA · Traditional | 10/04/2006SE |
| K061103 | Haemonetics 40U RBC Filter BagCAK · Traditional | 05/17/2006SE |
| K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)CAC · Special | 11/21/2005SE |
| K052626 | Smartsuction Harmony DeviceBTA · Traditional | 10/05/2005SE |
| K043127 | Haemonetics Cardiovascular Perioperative Autotransfusion SystemCAC · Traditional | 01/04/2005SE |
| K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery SystemCAC · Special | 01/08/2002SE |
| K993581 | Haemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2…CAC · Special | 11/18/1999SE |
| K953681 | Haemonetics Therapeutic Plasma Exchange SetLKN · Traditional | 06/04/1996SE |
| K944232 | Autoflo Intra-Op Shed Blood Autortransfustion SysCAC · Traditional | 07/20/1995SE |
| K932890 | Cell Saver 5 SystemCAC · Traditional | 01/05/1994SE |
| K904474 | Haemonetics LN 200F Collection ReservoirCAC · Traditional | 11/13/1990SE |
| K904041 | Haemonetics Cell Saver 4 PlusCAC · Traditional | 11/13/1990SE |
| K893394 | Orthopedic Wound Drainage Set with TrocarCAC · Traditional | 10/19/1989SE |
| K883934 | Cell Saver Haemolite B Auto. Blood Recovery SystemCAC · Traditional | 12/27/1988SE |
| K872895 | Haemonetics Cell Saver Mini Saver Auto. Blood Sys.CAL · Traditional | 01/11/1988SE |
| K860969 | Fluid Management System (Modified)FRN · Traditional | 05/06/1986SE |
| K852645 | Fluid Management SystemFRN · Traditional | 12/09/1985SE |
| K852425 | Cell Saver Suction SystemCAC · Traditional | 09/03/1985SE |
| K811449 | Haemonetics 1000ML Component BagKSR · Traditional | 07/01/1981SE |
| K810711 | Haemonetics 600 Ml. Component BagKSR · Traditional | 05/08/1981SE |
| K810365 | Haemonetics 170 Y Infusion SetFPA · Traditional | 03/31/1981SE |
| K810313 | Haemonetics 1400 ML Therapeutic BagKSR · Traditional | 03/31/1981SE |
| K810076 | Pheresis Needle AssemblyGAA · Traditional | 03/05/1981SE |
| K802674 | Reservoir for Autologous Blood Transfus.CAC · Traditional | 01/08/1981SE |
| K800358 | Y-Type Infusion Set (2 Lead)FPA · Traditional | 04/16/1980SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1310-2022 Class II | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU… | 04/26/2022Terminated |
| Z-1298-2022 Class II | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030…When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays… | 04/19/2022Terminated |
| Z-1617-2020 Class II | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0…Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this… | 02/19/2020Terminated |
| Z-0906-2020 Class II | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0905-2020 Class II | Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0904-2020 Class II | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0903-2020 Class II | JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0902-2020 Class II | JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0901-2020 Class II | Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0900-2020 Class II | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0899-2020 Class II | JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0898-2020 Class II | JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0897-2020 Class II | JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0896-2020 Class II | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0895-2020 Class II | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0894-2020 Class II | CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0893-2020 Class II | CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0892-2020 Class II | CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0891-2020 Class II | Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0890-2020 Class II | CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0889-2020 Class II | CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0888-2020 Class II | CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0887-2020 Class II | High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0886-2020 Class II | CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-0885-2020 Class II | CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | 10/21/2019Terminated |
| Z-2951-2018 Class II | Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The…OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the… | 07/13/2018Terminated |
| Z-2950-2018 Class II | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic…OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the… | 07/13/2018Terminated |
| Z-0779-2019 Class II | Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The…Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell… | 08/02/2017Terminated |
| Z-0778-2019 Class II | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The…Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell… | 08/02/2017Terminated |
| Z-1130-2015 Class II | Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II…Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the… | 01/26/2015Terminated |
| Z-1796-2013 Class II | TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for…Research Use Only (RUO) parameters were included in TEG 5000 User Manual. | 06/20/2013Terminated |
| Z-2956-2011 | Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US…Updated Operations Manual for the deployment of the spill collection system and cleaning | 07/27/2011Terminated |
| Z-2420-2011 | Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only:…2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for… | 04/29/2011Terminated |
| Z-1899-2011 | 2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The…Battery pack may have exposed wire becoming hot | 01/31/2011Terminated |
| Z-1391-2011 | Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-USUpdate Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the… | 01/25/2011Terminated |
| Z-0358-2008 | Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation…Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to… | 10/15/2007Terminated |
| Z-0035-2007 | SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-USFaulty circuit board may short circuit and cause electric shock to operator | 07/28/2006Terminated |