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Sorin Group Usa, Inc. Recalls

32 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Sorin Group Usa, Inc..

32Total Recalls
0Critical
157,763Units Affected
Jun 30, 2017Most Recent
All Recalls

Every Sorin Group Usa, Inc. Recall

Sorted by most recent. Click any recall for full details.

32 recalls
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medical Devices·4 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Medical Devices·98 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
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
Medical Devices·733 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Medical Devices·52 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Medical Devices·524 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Medical Devices·8 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Medical Devices·5 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
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 us...
Medical Devices·105,770 affected·Jun 9, 2017
High RiskFDA
Sorin Group Usa, Inc.
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, ...
Medical Implants·845 affected·Oct 31, 2016
High RiskFDA
Sorin Group Usa, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pac...
Medical Implants·586 affected·Sep 29, 2016
High RiskFDA
Sorin Group Usa, Inc.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be ...
Medical Devices·200 affected·Aug 12, 2016
High RiskFDA
Sorin Group Usa, Inc.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Can...
Surgical Devices·5,740 affected·Jun 22, 2016
High RiskFDA
Sorin Group Usa, Inc.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Produ...
Surgical Devices·60 affected·Jan 25, 2016
RecallFDA
Sorin Group Usa, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: H...
Cardiac Devices·6,859 affected·Jan 19, 2016
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·1,755 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·2,837 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·283 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·28 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a...
Medical Devices·8 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopul...
Medical Devices·12 affected·Sep 20, 2012
High RiskFDA
Sorin Group Usa, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass f...
Medical Devices·5 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass ...
Medical Devices·35 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass fo...
Medical Devices·2 affected·Sep 19, 2012
High RiskFDA
Sorin Group Usa, Inc.
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Medical Devices·1,125 affected·Aug 15, 2012