Device, Pasteurization, Hot Water
General Hospital · 21 CFR 880.6991
Recent MDR events
95 adverse event reports on file
- STERILE-DRIER 44Jun 29, 2016MalfunctionNatus Medical Incorporated3018859-2016-00002
- HAMO LS2000 WASHEROct 8, 2015Steris Gmbh1527821-2015-00001
- RELIANCE 120 CART WASHEROct 23, 2013Steris Canada Corporation9680353-2013-00140
- 120L CART WASHEROct 9, 2013Steris Canada Corporation9680353-2013-00134
- 220 CART WASHERJul 18, 2013Steris Canada Corporation9680353-2013-00084
- RELIANCE SYNERGY WASHERFeb 21, 2013Steris Canada Corporation9680353-2013-00017
- RELIANCE 120 CART WASHERFeb 15, 2013Steris Canada Corporation9680353-2013-00014
- RELIANCE SYNERGY WASHERFeb 15, 2013Steris Canada Corporation9680353-2013-00015
- RELIANCE SYNERGY WASHERFeb 15, 2013Steris Canada Corporation9680353-2013-00016
- OLYMPIC PASTEURMATIC 3000Feb 8, 2013MalfunctionNatus Medical Inc3018859-2013-00002
Event type breakdown
Recalls
11 recall events for this product code
- Natus Medical IncorporatedTerminatedJun 1, 2016
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Z-1878-2016 · View FDA record ↗ - Cenorin, LLCTerminatedJul 6, 2014
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
Z-1995-2014 · View FDA record ↗ - Cenorin, LLCTerminatedJun 6, 2014
HLD Systems Model 610 Washer/High Level Disinfector.
Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
Z-1729-2014 · View FDA record ↗ - CenorinTerminatedOct 12, 2010
HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is rivete
The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized with enough wat
Z-0036-2011 · View FDA record ↗ - CenorinTerminatedOct 12, 2010
HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit kno
The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized
Z-0037-2011 · View FDA record ↗ - CenorinTerminatedOct 12, 2010
The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). The Model 540HT has an external heater (aka High T
The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized
Z-0038-2011 · View FDA record ↗ - CenorinTerminatedOct 12, 2010
The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Ken
The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized
Z-0039-2011 · View FDA record ↗ - CenorinTerminatedApr 4, 2007
ThermaSure Medical Device Drying Cabinet, series 130
Potential for user to receive an electrical shock.
Z-0711-2007 · View FDA record ↗ - CenorinTerminatedApr 4, 2007
ThermaSure Medical Device Drying Cabinet, series 300
Potential for user to receive an electrical shock.
Z-0712-2007 · View FDA record ↗ - CenorinTerminatedApr 4, 2007
ThermaSure Medical Device Drying Cabinet, series 1000
Potential for user to receive an electrical shock.
Z-0713-2007 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
W&h Sterilization S.r.l.
BRUSAPORTO Bergamo, IT
Tuttnauer Ltd.
BEIT SHEMESH Jerusalem, IL
Scican Ltd.
TORONTO Ontario, CA
Cefla S.c.
IMOLA Bologna, IT
Cenorin, Llc
KENT, WA, US
Miele Inc.
Princeton, NJ, US
Oketz Logistics Llc
Coral Gables, FL, US
Dent4you Ag
Heerbrugg Sankt Gallen, CH
At-os S.r.l.
COLOGNOLA AI COLLI Verona, IT
Scientek Technology Corporation
Delta British Columbia, CA
510(k) clearances
11 clearances for this product code
- Cenorin, LLCSep 9, 2019
K183444 · Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
- Miele, Inc.Nov 12, 2003
K031799 · MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
- STERIS CorporationMay 31, 2000
K983068 · RELIANCE FAMILY OF WASHER-DISINFECTORS
- Olympic Medical Corp.Sep 5, 1997
K972193 · OLYMPIX MINI-PASTEURMATIC (58210)
- Miele ProfessionalJan 26, 1996
K950518 · MIELE G 7781 DENTAL THERMAL DISINFECTOR
- Getinge Disinfection, Inc.Oct 19, 1995
K950566 · DECOMAT 4656
- Olympic Medical Corp.Sep 22, 1995
K953645 · OLYMPIC PASTEURMATIC SYSTEM
- Miele Appliances, Inc.May 16, 1989
K884151 · MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.