Haemonetics Recalls
31 recalls on record · July 31, 2013 to July 6, 2022 · Medical Devices
Recalls by year
13
15
18
19
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 6, 2022Medical DevicesFDA
Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Hazard: 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.
July 6, 2022Medical DevicesFDA
Haemonetics Corporation recalls Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping A
Hazard: 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.
April 8, 2020Medical DevicesFDA
Haemonetics Corporation recalls 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: Fo
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recove
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recove
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blo
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blo
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood s
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to reco
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recove
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recove
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the r
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the r
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended fo
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended fo
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended t
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intende
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used
Hazard: 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.
February 5, 2020Medical DevicesFDA
Haemonetics Corporation recalls CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended
Hazard: 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.
February 6, 2019Medical DevicesFDA
Haemonetics Corporation recalls Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ Sys
Hazard: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
February 6, 2019Medical DevicesFDA
Haemonetics Corporation recalls Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ S
Hazard: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
September 5, 2018Medical DevicesFDA
Haemonetics Corporation recalls Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic periope
Hazard: 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.
September 5, 2018Medical DevicesFDA
Haemonetics Corporation recalls Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusio
Hazard: 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.
February 25, 2015Medical DevicesFDA
Haemonetics Corporation recalls Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control f
Hazard: 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.