System, thermal regulating
FDA product code DWJ · Class 2 · 97 devices · 14,800 reports · 6 deaths reported · 15 devices named in recalls
- Arctic Sun® 5000 50000000Medivance, Inc. · System, thermal regulating1 recall3 deaths6,903 reports
- Arctic Sun® 5000 50000000EMedivance, Inc. · System, thermal regulating1 recall2 deaths4,413 reports
- Arctic Sun Stat 60000000Medivance, Inc. · System, thermal regulating1 recall1,613 reports
- Arctic Sun® 5000 50000000LMedivance, Inc. · System, thermal regulating1 recall388 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802Medivance, Inc. · System, thermal regulating1 recall385 reports
- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- HotDog Temperature Management System WC71Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
- Hillrom powered by Augustine Surgical HD 2083516Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31705Medivance, Inc. · System, thermal regulating90 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31707Medivance, Inc. · System, thermal regulating90 reports
- WarmTouch 5016000Covidien LP · System, thermal regulating82 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31709Medivance, Inc. · System, thermal regulating79 reports
- Arctic Sun® Temperature Management System, Fluid Delivery Lines 73407Medivance, Inc. · System, thermal regulating75 reports
- CritiCool 200-00236Belmont Instrument Corporation · System, Thermal Regulating1 recall1 death11 reports
- Norm-O-Temp® 111ZGentherm Medical, LLC · System, Thermal Regulating1 recall2 reports
- HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") U501Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
- HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") U502Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
- HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35") U530Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
- Level 1 EQ-5000Icu Medical, Inc. · System, thermal regulating46 reports
- Arctic Sun® Temperature Management System, Temperature Cable Nellcor 73502Medivance, Inc. · System, thermal regulating43 reports
- Arctic Sun® Temperature Management System, Fill Tube 71800Medivance, Inc. · System, thermal regulating37 reports
- Level 1 L1-CW-120VIcu Medical, Inc. · System, thermal regulating30 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31700Medivance, Inc. · System, thermal regulating24 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31703Medivance, Inc. · System, thermal regulating13 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31801Medivance, Inc. · System, thermal regulating13 reports
- CureWrap™ Infant, 4-7Kg (single) 500-03521Belmont Instrument Corporation · System, Thermal Regulating13 reports
- Mul-T-Blanket 8001-061-610Stryker Corporation · System, thermal regulating13 reports
- Arctic Sun® Temperature Management System, Calibration Test Unit 74100Medivance, Inc. · System, thermal regulating10 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31702Medivance, Inc. · System, thermal regulating9 reports
- Hot Dog Underbody Warming Mattress, 127 cm (50in) U102Augustine Temperature Management LLC · System, Thermal Regulating8 reports
- CureWrap™ Infant, 2.5-4Kg 500-03518Belmont Instrument Corporation · System, Thermal Regulating8 reports
- Level 1 SWU-2001Icu Medical, Inc. · System, thermal regulating8 reports
- Level 1 SW5-HOSE-7Icu Medical, Inc. · System, thermal regulating7 reports
- Arctic Sun® Temperature Management System, Temperature Cable Bard 73503Medivance, Inc. · System, thermal regulating6 reports
- Mul-T-Blanket 8001-061-810Stryker Corporation · System, thermal regulating6 reports
- Blanketrol® lll 233Gentherm Medical, LLC · System, Thermal Regulating6 reports
- Arctic Sun® Temperature Management System, Power Cord 73300Medivance, Inc. · System, thermal regulating5 reports
- Arctic Sun® Temperature Management System, Temperature Out Cable Philips 73556Medivance, Inc. · System, thermal regulating5 reports
- Allon® 200-00263Belmont Instrument Corporation · System, Thermal Regulating5 reports
- Rapr-Round 8001-061-540Stryker Corporation · System, thermal regulating5 reports
- Bair Hugger™ 775003m Company · System, thermal regulating4 reports
- Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector 73552Medivance, Inc. · System, thermal regulating4 reports
- Level 1 SWU-2113Icu Medical, Inc. · System, thermal regulating4 reports
- Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line 73490Medivance, Inc. · System, thermal regulating3 reports
- Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE 73555Medivance, Inc. · System, thermal regulating3 reports
- Level 1 SWU-2003Icu Medical, Inc. · System, thermal regulating3 reports
- Level 1 SWU-2009Icu Medical, Inc. · System, thermal regulating3 reports
- Nova AW5100-300Encompass Group, L.L.C. · System, Thermal Regulating2 reports
- 3M™ Bair Hugger™ 875003m Company · System, thermal regulating2 reports
- Arctic Sun® Temperature Management System, Temperature Cable Phono 73505Medivance, Inc. · System, thermal regulating2 reports
- Hot Dog Chest and Torso Warming Blanket B110Augustine Temperature Management LLC · System, Thermal Regulating2 reports
- CureWrap™ Adult Over 135 cm 500-03500Belmont Instrument Corporation · System, Thermal Regulating2 reports
- CureWrap™ Pediatric 91-104cm, (single) 500-03536Belmont Instrument Corporation · System, Thermal Regulating2 reports
- Mul-T-Blanket 8001-061-701Stryker Corporation · System, thermal regulating2 reports
- Level 1 SWU-2013Icu Medical, Inc. · System, thermal regulating2 reports
- WarmAir® 135Gentherm Medical, LLC · System, Thermal Regulating2 reports
- Kool Kit® 900Gentherm Medical, LLC · System, Thermal Regulating2 reports
- WarmTouch 5030850Covidien LP · System, thermal regulating2 reports
- WarmTouch 5030810Covidien LP · System, thermal regulating2 reports
- WarmTouch 5030870Covidien LP · System, thermal regulating2 reports
- Bair Paws™ 875003m Company · System, thermal regulating1 report
- 3M™ Bair Hugger™ 675003m Company · System, thermal regulating1 report
- Arctic Sun® Temperature Management System, Transmission Interface Module Kit 76000Medivance, Inc. · System, thermal regulating1 report
- Hot Dog Multi-Position Warming Blanket B105Augustine Temperature Management LLC · System, Thermal Regulating1 report
- Hot Dog Underbody Warming Mattress, 82 cm (32in) U101Augustine Temperature Management LLC · System, Thermal Regulating1 report
- KoZee Warming Unit M21507Jiangmen Dacheng Medical Equipment Co., Ltd. · System, Thermal Regulating1 report
- ThermoWrap™ Universal 135-152cm, (single) 500-03153Belmont Instrument Corporation · System, Thermal Regulating1 report
- ThermoWrap™ Universal 152-168cm (single) 500-03160Belmont Instrument Corporation · System, Thermal Regulating1 report
- CureWrap™ Pediatric 122–135cm (single) 500-03548Belmont Instrument Corporation · System, Thermal Regulating1 report
- CureWrap™ Infant (single)Belmont Instrument Corporation · System, Thermal Regulating1 report
- Barrier® EasyWarm® 629905Mölnlycke Health Care AB · System, thermal regulating1 report
- NA DP400CEStryker Corporation · System, thermal regulating1 report
- Mul-T-Blanket 8001-061-812Stryker Corporation · System, thermal regulating1 report
- Rapr-Round 8001-061-530Stryker Corporation · System, thermal regulating1 report
- Rapr-Round 8001-061-535Stryker Corporation · System, thermal regulating1 report
- Rapr-Round 8001-061-560Stryker Corporation · System, thermal regulating1 report
- Rapr-Round 8001-061-550Stryker Corporation · System, thermal regulating1 report
- Insulated Colder Connector 8001-064-135Stryker Corporation · System, thermal regulating1 report
- Rapr Round 8001-061-640Stryker Corporation · System, thermal regulating1 report
- Altrix Temperature Management Wraps 8003-003-001Stryker Corporation · System, thermal regulating1 report
- Kozee M21505Sourcemark, LLC. · System, Thermal Regulating1 report
- Level 1 SWU-2002Icu Medical, Inc. · System, thermal regulating1 report
- Level 1 SWU-2010Icu Medical, Inc. · System, thermal regulating1 report
- Level 1 SWU-2011Icu Medical, Inc. · System, thermal regulating1 report
- Blanketrol 233Gentherm Medical, LLC · System, Thermal Regulating1 report
- WarmTouch 5016000-RCCovidien LP · System, thermal regulating1 report
- Level 1 L1-HoseIcu Medical, Inc. · System, thermal regulating1 report
- Level 1 EQ-5000 115VIcu Medical, Inc. · System, thermal regulating1 report
- FilteredFlo® Lower Body OR Blanket 460Gentherm Medical, LLC · System, Thermal Regulating1 report
- Kool Kit® Neonate 950Gentherm Medical, LLC · System, Thermal Regulating1 report
- Level 1 SW-2003Icu Medical, Inc. · System, thermal regulating1 report
- Level 1 EQ-5000-INT-115VIcu Medical, Inc. · System, thermal regulating1 report
- Level 1 EQ-5000HF-EN-115VIcu Medical, Inc. · System, thermal regulating1 report
- Bair Hugger™ 635003m Company · System, thermal regulating1 report
- 3M™ Bair Hugger™ 630003m Company · System, thermal regulating1 report