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Sorin Group USA, Inc.

113 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
STOCKERT Heater-Cooler System 3T, 230 V recall (Z-2771-2017)Sorin Group USA, Inc.2017-07-25
STOCKERT Heater-Cooler System 3T, 240V/60 Hz recall (Z-2772-2017)Sorin Group USA, Inc.2017-07-25
STOCKERT Heater-Cooler System 3T, 208V/60 Hz recall (Z-2773-2017)Sorin Group USA, Inc.2017-07-25
STOCKERT Heater-Cooler System 3T, 127V/60 Hz recall (Z-2774-2017)Sorin Group USA, Inc.2017-07-25
STOCKERT Heater-Cooler System 3T, 120V/60 Hz recall (Z-2775-2017)Sorin Group USA, Inc.2017-07-25
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz recall (Z-2776-2017)Sorin Group USA, Inc.2017-07-25
STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Numbe recall (Z-0682-2017)Sorin Group USA, Inc.2016-12-01
Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine consol recall (Z-2866-2016)Sorin Group USA, Inc.2016-09-21
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6 recall (Z-2756-2016)Sorin Group USA, Inc.2016-09-08
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery recall (Z-2757-2016)Sorin Group USA, Inc.2016-09-08
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part recall (Z-2147-2016)Sorin Group USA, Inc.2016-07-08
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 1 recall (Z-1186-2016)Sorin Group USA, Inc.2016-03-17
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model recall (Z-0813-2016)Sorin Group USA, Inc.2016-02-16
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of recall (Z-2076-2015)Sorin Group USA, Inc.2015-07-15
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perf recall (Z-2077-2015)Sorin Group USA, Inc.2015-07-15
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perf recall (Z-2078-2015)Sorin Group USA, Inc.2015-07-15
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perf recall (Z-2079-2015)Sorin Group USA, Inc.2015-07-15
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perf recall (Z-2080-2015)Sorin Group USA, Inc.2015-07-15
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorpore recall (Z-2081-2015)Sorin Group USA, Inc.2015-07-15
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusio recall (Z-1985-2013)Sorin Group USA, Inc.2013-08-20
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead mod recall (Z-0928-2013)Sorin Group USA, Inc.2013-03-08
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intend recall (Z-0271-2013)Sorin Group USA, Inc.2012-11-08
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intende recall (Z-0272-2013)Sorin Group USA, Inc.2012-11-08
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended recall (Z-0273-2013)Sorin Group USA, Inc.2012-11-08
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended recall (Z-0274-2013)Sorin Group USA, Inc.2012-11-08
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intende recall (Z-0275-2013)Sorin Group USA, Inc.2012-11-08
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S0912 recall (Z-0166-2013)Sorin Group USA, Inc.2012-10-29
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S0913 recall (Z-0167-2013)Sorin Group USA, Inc.2012-10-29
Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot recall (Z-0157-2013)Sorin Group USA, Inc.2012-10-25
Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1 recall (Z-0158-2013)Sorin Group USA, Inc.2012-10-25
Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrass recall (Z-1149-2012)Sorin Group USA, Inc.2012-03-05
Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindbergh recall (Z-1150-2012)Sorin Group USA, Inc.2012-03-05
Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, recall (Z-1151-2012)Sorin Group USA, Inc.2012-03-05
S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschla recall (Z-1152-2012)Sorin Group USA, Inc.2012-03-05
S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschlan recall (Z-1153-2012)Sorin Group USA, Inc.2012-03-05
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROL recall (Z-1154-2012)Sorin Group USA, Inc.2012-03-05
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST recall (Z-1155-2012)Sorin Group USA, Inc.2012-03-05
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUM recall (Z-1156-2012)Sorin Group USA, Inc.2012-03-05
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROL recall (Z-1157-2012)Sorin Group USA, Inc.2012-03-05
SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 809 recall (Z-1158-2012)Sorin Group USA, Inc.2012-03-05
Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th W recall (Z-0760-2012)Sorin Group USA, Inc.2012-01-14
Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: recall (Z-0761-2012)Sorin Group USA, Inc.2012-01-14
Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin recall (Z-0762-2012)Sorin Group USA, Inc.2012-01-14
Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Grou recall (Z-0763-2012)Sorin Group USA, Inc.2012-01-14
Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sor recall (Z-0764-2012)Sorin Group USA, Inc.2012-01-14
Apex HP PHisio SMART Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. b recall (Z-0765-2012)Sorin Group USA, Inc.2012-01-14
D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin recall (Z-0766-2012)Sorin Group USA, Inc.2012-01-14
D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Gr recall (Z-0767-2012)Sorin Group USA, Inc.2012-01-14
PRIMO2X Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Grou recall (Z-0768-2012)Sorin Group USA, Inc.2012-01-14
SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung recall (Z-0769-2012)Sorin Group USA, Inc.2012-01-14
Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: S recall (Z-0770-2012)Sorin Group USA, Inc.2012-01-14
PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group recall (Z-0771-2012)Sorin Group USA, Inc.2012-01-14
Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghs recall (Z-0956-2011)Sorin Group USA, Inc.2011-01-26
Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lind recall (Z-0957-2011)Sorin Group USA, Inc.2011-01-26
S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindbergh recall (Z-0958-2011)Sorin Group USA, Inc.2011-01-26
S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindbergh recall (Z-0959-2011)Sorin Group USA, Inc.2011-01-26
S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland G recall (Z-0960-2011)Sorin Group USA, Inc.2011-01-26
SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany, Dis recall (Z-0961-2011)Sorin Group USA, Inc.2011-01-26
2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Ge recall (Z-0962-2011)Sorin Group USA, Inc.2011-01-26
SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany, Dist recall (Z-0963-2011)Sorin Group USA, Inc.2011-01-26
S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munc recall (Z-0964-2011)Sorin Group USA, Inc.2011-01-26
SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distrib recall (Z-0965-2011)Sorin Group USA, Inc.2011-01-26
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Gro recall (Z-0370-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin Gro recall (Z-0371-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin Gro recall (Z-0372-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Gro recall (Z-0373-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Gro recall (Z-0374-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin Gro recall (Z-0375-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Gro recall (Z-0376-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Gro recall (Z-0377-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600, Manufactured by Sorin Gro recall (Z-0378-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700, Manufactured by Sorin Gro recall (Z-0379-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Gro recall (Z-0380-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin Gro recall (Z-0381-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, Manufactured by Sorin Gro recall (Z-0382-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200, Manufactured by Sorin Gro recall (Z-0383-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000, Manufactured by Sorin Gro recall (Z-0384-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100, Manufactured by Sorin Gro recall (Z-0385-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin Gro recall (Z-0386-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400, Manufactured by Sorin Gro recall (Z-0387-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500, Manufactured by Sorin Gro recall (Z-0388-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin Gro recall (Z-0389-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin Gro recall (Z-0390-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Gro recall (Z-0391-2011)Sorin Group USA, Inc.2010-11-15
Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5. recall (Z-2073-2010)Sorin Group USA, Inc.2010-07-22
B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5. recall (Z-2074-2010)Sorin Group USA, Inc.2010-07-22
Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5. recall (Z-2075-2010)Sorin Group USA, Inc.2010-07-22
Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W recall (Z-1084-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1085-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1086-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1087-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1088-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1089-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1090-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1091-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1092-2010)Sorin Group USA, Inc.2010-03-12
Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arva recall (Z-1093-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1094-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1095-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1096-2010)Sorin Group USA, Inc.2010-03-12
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