Sorin Group Usa recalls
Sorin Group Usa appears in 52 official U.S. recall notices indexed by RecallRadar, most recently on 2017-11-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device
FDA Device · Class II · 2017-11-15 · Sorin Group Usa - Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in p…
FDA Device · Class II · 2017-08-16 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 120V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 240V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 127V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 208V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 230 V
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21
FDA Device · Class II · 2016-12-14 · Sorin Group Usa - ST¿CKERT HeaterCooler System 3T
FDA Device · Class II · 2016-12-07 · Sorin Group Usa - The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and…
FDA Device · Class II · 2016-11-23 · Sorin Group Usa - The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemaker…
FDA Device · Class II · 2016-11-23 · Sorin Group Usa - St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is inten…
FDA Device · Class II · 2016-09-28 · Sorin Group Usa - Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consi…
FDA Device · Class II · 2016-09-14 · Sorin Group Usa - Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6)
FDA Device · Class II · 2016-09-14 · Sorin Group Usa - AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae…
FDA Device · Class II · 2016-07-20 · Sorin Group Usa - Stockert Heater-Cooler 3T
FDA Device · Class II · 2016-03-23 · Sorin Group Usa - CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack
FDA Device · Class III · 2016-03-02 · Sorin Group Usa - Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product…
FDA Device · Class II · 2016-02-24 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs
FDA Device · Class II · 2013-08-28 · Sorin Group Usa - Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia…
FDA Device · Class II · 2013-03-20 · Sorin Group Usa - Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pr…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pro…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for proc…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for pr…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for p…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954
FDA Device · Class II · 2012-11-07 · Sorin Group Usa - SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139
FDA Device · Class II · 2012-11-07 · Sorin Group Usa