Haemonetics Corporation
Boston, MA, US
Haemonetics Corporation appears in FDA device records in Boston, MA. FDA records list 36 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 46 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 36 510(k) clearances for Haemonetics Corporation between 1980 and 2025. The busiest year on record is 1981, with 6. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 6 |
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2005 | 3 |
| 2006 | 2 |
| 2010 | 1 |
| 2012 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | JPA | Substantially Equivalent | |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | JPA | Substantially Equivalent | |
| K232018 | Citrated: K, KH, RTH, FFH | JPA | Substantially Equivalent | |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | CAC | Substantially Equivalent | |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | JPA | Substantially Equivalent | |
| K160502 | TEG 6s Hemostasis System | JPA | Substantially Equivalent | |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | CAC | Substantially Equivalent | |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | CAC | Substantially Equivalent | |
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K120586 | CELL SAVER ELITE | CAC | Substantially Equivalent | |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K062801 | SMARTSUCTION SOLO DEVICE | BTA | Substantially Equivalent | |
| K061103 | HAEMONETICS 40U RBC FILTER BAG | CAK | Substantially Equivalent | |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) | CAC | Substantially Equivalent | |
| K052626 | SMARTSUCTION HARMONY DEVICE | BTA | Substantially Equivalent | |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | CAC | Substantially Equivalent | |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | CAC | Substantially Equivalent | |
| K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | LKN | Substantially Equivalent | |
| K944232 | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS | CAC | Substantially Equivalent | |
| K932890 | CELL SAVER 5 SYSTEM | CAC | Substantially Equivalent | |
| K904474 | HAEMONETICS LN 200F COLLECTION RESERVOIR | CAC | Substantially Equivalent | |
| K904041 | HAEMONETICS CELL SAVER 4 PLUS | CAC | Substantially Equivalent | |
| K893394 | ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR | CAC | Substantially Equivalent | |
| K883934 | CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM | CAC | Substantially Equivalent | |
| K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | CAL | Substantially Equivalent | |
| K860969 | FLUID MANAGEMENT SYSTEM (MODIFIED) | FRN | Substantially Equivalent | |
| K852645 | FLUID MANAGEMENT SYSTEM | FRN | Substantially Equivalent | |
| K852425 | CELL SAVER SUCTION SYSTEM | CAC | Substantially Equivalent | |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | KSR | Substantially Equivalent | |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | KSR | Substantially Equivalent | |
| K810365 | HAEMONETICS 170 Y INFUSION SET | FPA | Substantially Equivalent | |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | KSR | Substantially Equivalent | |
| K810076 | PHERESIS NEEDLE ASSEMBLY | GAA | Substantially Equivalent | |
| K802674 | RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS. | CAC | Substantially Equivalent | |
| K800358 | Y-TYPE INFUSION SET (2 LEAD) | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219343 | 1219343 | HAEMONETICS CORPORATION | 125 Summer Street, Boston, MA 02110 US | 2026 | and 5 more, listed in full below |
| 3011773324 | 3011773324 | Haemonetics Corporation | 1555 South Gramercy Rd, Salt Lake City, UT 84104 US | 2026 | |
| 3019849102 | 3019849102 | Haemonetics Corporation | 1300 Clifford Ball Drive, Clinton, PA 15026 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JBPActivated Whole Blood Clotting Time
- CACApparatus, Autotransfusion
- MMHBlood Establishment Computer Software And Accessories
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- PPMGeneral Purpose Reagent
- CALLaryngoscope, Non-Rigid
- OUGMedical Device Data System
- CAKMicrofilter, Blood Transfusion
- GAANeedle, Aspiration And Injection, Disposable
- GGNPlasma, Coagulation Control
- FRNPump, Infusion
- BTAPump, Portable, Aspiration (Manual Or Powered)
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- GKTSeparator, Automated, Blood Cell, Diagnostic
- FPASet, Administration, Intravascular
- JOZSystem, Automated Platelet Aggregation
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- KSWSystem, Processing For Frozen Blood
Recall records
Showing 25 of 46| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1310-2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat. | Class II | Terminated | |
| Z-1298-2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1) | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays. | Class II | Terminated | |
| Z-1617-2020 | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa. | Class II | Terminated | |
| Z-0906-2020 | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0905-2020 | Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0904-2020 | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0903-2020 | JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0902-2020 | JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0901-2020 | Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0900-2020 | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0899-2020 | JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0898-2020 | JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0897-2020 | JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0896-2020 | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0895-2020 | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0894-2020 | CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0893-2020 | CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0892-2020 | CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0891-2020 | Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0890-2020 | CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0889-2020 | CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0888-2020 | CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0887-2020 | High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0886-2020 | CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated | |
| Z-0885-2020 | CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain