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    Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·September 25, 2012

    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·April 14, 2014

    Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system.

    FDA Recall
    Terminated ·Levitronix, Llc·Product code KFM·March 17, 2008

    TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code KFM·March 6, 2020

    SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KFM·December 2, 2011

    Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·September 25, 2012

    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code KFM·August 7, 2020

    Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KFM·December 12, 2006

    Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KFM·July 26, 2005

    Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KFM·September 25, 2009

    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·September 24, 2012

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    FDA Recall
    Terminated ·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·August 22, 2019

    Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·September 24, 2012

    Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code KFM·September 25, 2009

    Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·April 14, 2014

    Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. CV-164275 is an item number for product that is sold to foreign affiliate. Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code KFM·March 15, 2010

    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

    FDA Recall
    Terminated ·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·September 5, 2018

    TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code KFM·March 6, 2020

    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KFM·May 27, 2015

    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code KFM·March 6, 2020