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Manufacturers
Sorin Group USA, Inc.
Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA
42 Events
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Recall of Device Recall CDl H/S Cuvette Perfusion Pack or Smart Perfusion Pack
Recall of Device Recall Dual Stage Venous Return Catheter
Recall of Device Recall AORTIC ARCH CANNULA
Recall of Device Recall Stckert S5 System
Recall of Device Recall Cardiopulmonary Bypass Catheter Cannula and Tubing
Recall of Device Recall SMART PERFUSION PACK, NEONATE/PEDIATRIC
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall HeaterCooler 3T
Recall of Device Recall SMART PERFUSION PACK, NEONATE/PEDIATRIC
Recall of Device Recall SMART PERFUSION PACK, TOTAL VISION SYSTEMSMA
Recall of Device Recall SMART PERFUSION PACK, INSPIRE 8S
Recall of Device Recall SMART PERFUSION PACK, SMART 1/4" PEDS PACK
Recall of Device Recall SMART PERFUSION PACK, INSPIRE 8FS
Recall of Device Recall SMART CARDIOPLEGIA, CARDIOPLEGIA PACK
Recall of Device Recall SMART PERFUSION PACK
Recall of Device Recall SMART PERFUSION PACK, LONG PACK
Recall of Device Recall SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK
Recall of Device Recall SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK
Recall of Device Recall SMART PERFUSION PACK, INSPIRE 6FS
Recall of Device Recall SMART PERFUSION PACK, SMART VENOUS VACUUM
Recall of Device Recall SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA3D
Recall of Device Recall SMART PERFUSION PACK, PUMP AND TABLE PACK
Recall of Device Recall SMART PERFUSION PACK, SMART 3/16" PEDS PACK
Recall of HeaterCooler 3T
Recall of Aortic Arch Cannula
Recall of Coronary Artery Perfusion Cannula with Balloon
Recall of ORCHESTRA and ORCHESTRA PLUS Programmers
Recall of ORCHESTRA PLUS Programmer
Recall of HeaterCooler 3T
Recall of FlexFlowTM venous cannula Catalog 200200
Recall of Device Recall Edwards Lifesciences Suction Wand Model S099B
Recall of Perceval Sutureless Heart Valve
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40 devices in the database
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Model / Serial
Product code 16-02-80 Serial number 16S10027-16S15641
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product Description
Sorin Stockert Heater-Cooler 3T, 230 V || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Model / Serial
Product code 16-02-81 Serial number 16S10743-16S11708
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product Description
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Model / Serial
Product code 16-02-82 Serial number 16S10772-16S15523
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product Description
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Model / Serial
Product code 16-02-83 Serial number 16S11455-16S15190
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product Description
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Model / Serial
Product code 16-02-85 Serial number 16S10958-16S15634
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Product Description
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
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2 manufacturers with a similar name
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Sorin Group USA, Inc.
Manufacturer Address
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA
Sorin Group USA, Inc.
Manufacturer Parent Company (2017)
LivaNova PLC
Manufacturers representative
Biomedic S.A.R.L.
Source
RLMPH
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