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Sterilizer, Ethylene-Oxide Gas

FDA product code FLF · Class 2 · General Hospital

30
Registered devices
66
Adverse events
8
Recalls
26
510(k) clearances

Devices with this code

EOGas 4 Refill Kit — ANDERSEN STERILIZERS INC.3M™ Steri-Vac™ — 3M COMPANYEOGas 4 Ethylene Oxide Gas Sterilizer — ANDERSEN STERILIZERS INC.EOGas 4 Refill Kit — ANDERSEN STERILIZERS INC.Anprolene AN75 Ethylene Oxide Sterilizer — ANDERSEN STERILIZERS INC.Steri-Vac™ — 3M COMPANY3M™ Steri-Vac™ — 3M COMPANYAnprolene AN75 Ethylene Oxide Gas Sterilizer, 230V — ANDERSEN STERILIZERS INC.EOGas 4 Refill Kit — ANDERSEN STERILIZERS INC.AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V — ANDERSEN STERILIZERS INC.Steri-Vac™ — 3M COMPANY3M™ Steri-Vac™ — 3M COMPANYEOGas 4 Sterilization Bag — ANDERSEN STERILIZERS INC.AN1071 Humidichip — ANDERSEN STERILIZERS INC.Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.STERRAD™ — ADVANCED STERILIZATION PRODUCTS SERVICES INC.Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V — ANDERSEN STERILIZERS INC.Anprolene AN75 Ethylene Oxide Sterilizer, 115V — ANDERSEN STERILIZERS INC.AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V — ANDERSEN STERILIZERS INC.Steri-Vac™ — 3M COMPANYAmsco Eagle — Steris Mexico, S. de R.L. de C.V.Anprolene AN75 Refill Kit, 14 Units — ANDERSEN STERILIZERS INC.3M™ Steri-Vac™ — 3M COMPANYAN1071 Humidichip — ANDERSEN STERILIZERS INC.

Recent recalls

DateFirmReason
2016-01-223M Company - Health Care Business3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remo
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not func
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not func
2014-03-173M Company - Health Care BusinessRecently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The ca
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected o
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected o
2012-09-133M Company - Health Care Business3M 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
2009-03-09Advanced Sterilization ProductsASP 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.