Sterilizer, Ethylene-oxide Gas
General Hospital · 21 CFR 880.6860
Recent MDR events
66 adverse event reports on file
- 3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1DNov 18, 2021Injury3m Health Care2110898-2021-00068
- 3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1DNov 18, 2021Injury3m Health Care2110898-2021-00067
- 3M¿ STERI-VAC¿ STERILIZER/AERATOR 5XL, 1 DOORNov 9, 2021Injury3m Health Care2110898-2021-00066
- OZONE GAS GENERATORJul 1, 2021InjuryUnkMW5102228
- 3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATORJan 4, 2019Injury3m Health Care2110898-2019-00002
- 3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATORJan 4, 2019Injury3m Health Care2110898-2019-00003
- 3017 ETO STERILIZERJun 2, 2017MalfunctionSteris Mexico, S. De R.l. De C.v.3005899764-2017-00025
- ETHYLENE OXIDE STERILANTFeb 15, 2017MalfunctionSteris Corporation1937531-2017-00003
- ETHYLENE OXIDE STERILANTFeb 8, 2017MalfunctionSteris Corporation1937531-2017-00002
- 3017 ETO STERILIZERDec 21, 2016Steris Mexico, S. De R.l. De C.v.3005899764-2016-00090
Event type breakdown
Recalls
8 recall events for this product code
- Advanced Sterilization ProductsTerminatedDec 22, 2014
STERRAD 50, Product Code 10114.
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Z-0842-2015 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedDec 22, 2014
STERRAD 100S, Product Code 10113.
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Z-0843-2015 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedApr 2, 2014
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL
Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20
Z-1318-2014 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedJan 14, 2014
STERRAD 50 Sterilization System, Product Code: 10050
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Z-0745-2014 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedJan 14, 2014
STERRAD 100S Sterilization System, Product Code: 10101
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
Z-0746-2014 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedOct 9, 2012
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL.
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Z-0022-2013 · View FDA record ↗ - Advanced Sterilization ProductsTerminatedJun 15, 2009
STERRAD 50 Sterilization System Product Code 10050
ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.
Z-1419-2009 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedUnknown
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
Z-1563-2016 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Arc Specialty Products, Balchem Corporation
Green Pond, SC, US
Advanced Sterilization Products
Irvine, CA, US
Solventum Us Llc
San Antonio, TX, US
Andersen Sterilizers, Inc.
Haw River, NC, US
Steris Mexico, S. De R.l. De C.v.
GUADALUPE Nuevo Leon, MX
Benchmark Electronics, Inc.
WINONA, MN, US
Solventum Us Llc
Eagan, MN, US
Asp Global Manufacturing Gmbh
SCHAFFHAUSEN, CH
Jabil Inc.
AUBURN HILLS, MI, US
510(k) clearances
26 clearances for this product code
- Andersen Sterilizers, Inc.Nov 12, 2020
K192978 · EOGas 4 Ethylene Oxide Gas Sterilizer
- Andersen Sterilizers, Inc.Oct 31, 2017
K170432 · Anprolene AN75 Ethylene Oxide Gas Sterilizer
- Andersen Sterilizers, Inc.Nov 18, 2015
K150646 · EOGas 4 Ethylene Oxide Gas Sterilizer
- 3M CompanyJan 8, 2015
K142034 · 3M STERI-VAC STERILIZER/AERATOR
- Tso3, Inc.Dec 2, 2009
K090636 · TSO3 OZONE STERILIZER, MODEL 125L
- Tso3, Inc.Jul 26, 2006
K051595 · TSO3 OZONE STERILIZER, MODEL 125L
- Technologies of Sterilization With Oxone, Tso3, Inc.Aug 26, 2003
K020875 · TSO3 OZONE STERILIZER, MODEL 125L
- H & W Technology, LLCJun 25, 2003
K014013 · H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM