Haemonetics Corporation recalls

30 recalls on record · latest: April 26, 2022

Official U.S. recall history for Haemonetics Corporation, compiled from official government records.

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Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

April 26, 2022 · Medical device recalls Moderate risk Due to a shift in the citrated blood reference range for a normal population, t…

Haemonetics Corporation recalls Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping…

April 19, 2022 · Medical device recalls Moderate risk When the TEG 5000 Analyzer including TEG Analytical Software is used with Plate…

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: For…

February 19, 2020 · Medical device recalls Moderate risk Software defect in TEG Manager impacts the displayed alert for out of range tes…

Haemonetics Corporation recalls JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover bl…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recov…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intende…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recov…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intende…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recov…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to rec…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended f…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intende…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intende…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recov…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intende…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended f…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intend…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover bl…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the…

October 21, 2019 · Medical device recalls Moderate risk Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver…

Haemonetics Corporation recalls Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion sy…

July 13, 2018 · Medical device recalls Moderate risk OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence…

Haemonetics Corporation recalls Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperat…

July 13, 2018 · Medical device recalls Moderate risk OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence…

Haemonetics Corporation recalls Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ Syste…

August 2, 2017 · Medical device recalls Moderate risk Haemonetics has received isolated reports that in some cases the 70ml centrifug…

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+ Sys…

August 2, 2017 · Medical device recalls Moderate risk Haemonetics has received isolated reports that in some cases the 70ml centrifug…

Haemonetics Corporation recalls Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for…

January 26, 2015 · Medical device recalls Moderate risk Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) resu…