Smisson-Cartledge Biomedical, LLC - ThermaCor - Class 1 Recall
ThermaCor 1200 Disposable Sets The Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2021 Category: Medical Devices Source Type: alerts
Smisson-Cartledge Biomedical, LLC - ThermaCor - Class 1 Recall
ThermaCor 1200 Disposable Sets The Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2021 Category: Medical Devices Source Type: alerts
Cincinnati Sub-Zero Products LLC, a Gentherm Company - Blanketrol II Model 233 HyperHyopthermia System and CoolBlue Model 2501 HyperHypothermia System - Class 2 Recall
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2019 Category: Medical Devices Source Type: alerts
Cincinnati Sub-Zero Products LLC, a Gentherm Company - Blanketrol II HyperHypothermia System, 222S - Class 2 Recall
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2019 Category: Medical Devices Source Type: alerts
Cincinnati Sub-Zero Products LLC, a Gentherm Company - CoolBlue Model 2501 HyperHypohermia System (Model Innercool) - Class 2 Recall
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2019 Category: Medical Devices Source Type: alerts
Cincinnati Sub-Zero Products LLC, a Gentherm Company - Hemotherm CE Dual Reservoir Cooler/Heater - Class 2 Recall
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2019 Category: Medical Devices Source Type: alerts
Cincinnati Sub-Zero Products LLC, a Gentherm Company - The Hemotherm Dual Reservoir Cooler/Heater - Class 2 Recall
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
3M Company - Health Care Business - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket - Class 2 Recall
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts
3M Company - Health Care Business - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket - Class 2 Recall
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts
Stryker Medical Division of Stryker Corporation - MediTherm Hyper/Hypothermia System, MTA7900 - Class 2 Recall
Medi-Therm Hyper/Hypothermia System, MTA7900 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2017 Category: Medical Devices Source Type: alerts
Thermedx LLC - Thermedx Fluid Management System - Class 2 Recall
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2014 Category: Medical Equipment Source Type: alerts
