BEUDAMED
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    Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 15, 2007

    Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·December 17, 2002

    Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·July 27, 2011

    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·January 26, 2015

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·July 13, 2018

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    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

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·February 19, 2020

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

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·April 26, 2022

    Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·April 29, 2011

    Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·December 21, 2005

    cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·July 22, 2005

    Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·December 21, 2005

    SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code BTA·July 28, 2006

    Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and 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.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·August 2, 2017