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HAEMONETICS CORPORATION

United States·US-MF-000034539

Last updated September 17, 2026

Information

Country: United States
Address: 125, Summer Street, Boston, United States
Website: haemonetics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)-537-2802
PRRC Contact: Julie Ryan
EUDAMED SRN: US-MF-000034539
FDA FEI Number: 3019849102
DUNS Number: 057827420

Catalogue (228)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Pheresis Needle Assembly	K810076	FDA 510(k)	Class I	Active
Smartsuction Solo Device	K062801	FDA 510(k)	Class II	Active
Haemonetics 170 Y Infusion Set	K810365	FDA 510(k)	Class II	Active
Citrated: K, KH, RTH, FFH	K232018	FDA 510(k)	Class II	Active
Haemonetics 1400 Ml Therapeutic Bag	K810313	FDA 510(k)	Class II	Active
Haemonetics Ln 193 Disposable Set, For Use With The Haemonetics Cellsever Haemolite 2 Family Of Autologous Blood Recover	K993581	FDA 510(k)	Class II	Active
TEG 6s Hemostasis System	K160502	FDA 510(k)	Class II	Active
Haemonetics 1000ml Component Bag	K811449	FDA 510(k)	Class II	Active
Reservoir For Autologous Blood Transfus.	K802674	FDA 510(k)	Class II	Active
Orthopat Advance Perioperative Autotransfusion System	K122262	FDA 510(k)	Class II	Active
Haemonetics Cell Saver Elite Autotransfusion System	K160197	FDA 510(k)	Class II	Active
Orthopedic Wound Drainage Set With Trocar	K893394	FDA 510(k)	Class II	Active
Haemonetics 600 Ml. Component Bag	K810711	FDA 510(k)	Class II	Active
Smartsuction Harmony Device	K052626	FDA 510(k)	Class II	Active
Haemonetics Cardiovascular Perioperative Autotransfusion System	K043127	FDA 510(k)	Class II	Active
Haemonetics Cell Saver Mini Saver Auto. Blood Sys.	K872895	FDA 510(k)	Class I	Active
Haemonetics 40u Rbc Filter Bag	K061103	FDA 510(k)	Class II	Active
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	K183160	FDA 510(k)	Class II	Active
Haemonetics Ln 200f Collection Reservoir	K904474	FDA 510(k)	Class II	Active
Fluid Management System (modified)	K860969	FDA 510(k)	Class II	Active
Haemonetics Cell Saver 4 Plus	K904041	FDA 510(k)	Class II	Active
Cell Saver Suction System	K852425	FDA 510(k)	Class II	Active
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System	K162423	FDA 510(k)	Class II	Active
BMB PLS Bowl	0625B-00	EUDAMEDFDA UDI	Class IIa	Active
NexSys PCS	PCS-300-INT	EUDAMED	Class IIb	Active
BMB PLS Bowl	0625B-JE	EUDAMED	Class IIa	Active
HS PLS Bowl	625HS-00	EUDAMED	Class IIa	Active
PLS Harness Set	00620-CP-CC	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Haemonetics Italia s.r.l IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (46)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 26, 2022	Z-1310-2022	—	terminated	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.
Apr 19, 2022	Z-1298-2022	—	terminated	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.
Feb 19, 2020	Z-1617-2020	—	terminated	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.
Oct 21, 2019	Z-0885-2020	—	terminated	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.
Oct 21, 2019	Z-0901-2020	—	terminated	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.
Oct 21, 2019	Z-0905-2020	—	terminated	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.
Oct 21, 2019	Z-0898-2020	—	terminated	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.
Oct 21, 2019	Z-0889-2020	—	terminated	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.
Oct 21, 2019	Z-0893-2020	—	terminated	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.
Oct 21, 2019	Z-0894-2020	—	terminated	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.
Oct 21, 2019	Z-0896-2020	—	terminated	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.
Oct 21, 2019	Z-0903-2020	—	terminated	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.
Oct 21, 2019	Z-0906-2020	—	terminated	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.
Oct 21, 2019	Z-0900-2020	—	terminated	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.
Oct 21, 2019	Z-0899-2020	—	terminated	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.
Oct 21, 2019	Z-0888-2020	—	terminated	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.
Oct 21, 2019	Z-0904-2020	—	terminated	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.
Oct 21, 2019	Z-0892-2020	—	terminated	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.
Oct 21, 2019	Z-0895-2020	—	terminated	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.
Oct 21, 2019	Z-0886-2020	—	terminated	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.
Oct 21, 2019	Z-0902-2020	—	terminated	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.
Oct 21, 2019	Z-0897-2020	—	terminated	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.
Oct 21, 2019	Z-0891-2020	—	terminated	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.
Oct 21, 2019	Z-0887-2020	—	terminated	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.
Oct 21, 2019	Z-0890-2020	—	terminated	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.
Jul 13, 2018	Z-2951-2018	—	terminated	OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
Jul 13, 2018	Z-2950-2018	—	terminated	OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
Aug 2, 2017	Z-0779-2019	—	terminated	Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Aug 2, 2017	Z-0778-2019	—	terminated	Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Jan 26, 2015	Z-1130-2015	—	terminated	Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
Jun 20, 2013	Z-1796-2013	—	terminated	Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Jul 27, 2011	Z-2956-2011	—	terminated	Updated Operations Manual for the deployment of the spill collection system and cleaning
Apr 29, 2011	Z-2420-2011	—	terminated	2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled Model 2: OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum
Jan 31, 2011	Z-1899-2011	—	terminated	Battery pack may have exposed wire becoming hot
Jan 25, 2011	Z-1391-2011	—	terminated	Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.
Oct 15, 2007	Z-0358-2008	—	terminated	Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
Jul 28, 2006	Z-0035-2007	—	terminated	Faulty circuit board may short circuit and cause electric shock to operator
Dec 21, 2005	Z-0822-06	—	terminated	Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
Dec 21, 2005	Z-0823-06	—	terminated	Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
Jul 22, 2005	Z-0174-06	—	terminated	Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System
Dec 17, 2002	Z-0502-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002	Z-0500-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002	Z-0498-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002	Z-0503-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002	Z-0499-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
Dec 17, 2002	Z-0501-03	—	terminated	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector