Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.
Recall
- Recall Number
- Z-0604-2020
- Event Number
- 84185
- Firm
- Steris Corporation
- FEI Number
- 1527821
- Product Code
- FLE
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- October 22, 2019
- Terminated
- May 6, 2020
- Address
- 5960 Heisley Rd, Mentor, OH, 44060-1834
Description
Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
On October 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT DEVICE FIELD CORRECTION ATTN: MATERIALS MANAGEMENT OR STERILE PROCESSING DEPARTMENT RE: Pressure Safety Valve Kit to Eagle 3000 Small Sterilizers Dear Valued STERIS Customer: STERIS Corporation is voluntarily implementing a field correction for Eagle 3000 Small Sterilizers that may have had an incorrect pressure safety valve installed. Safety valve kits with incorrect valves were shipped between July 17, 2019 - August 28, 2019. Our records indicate that your facility was shipped one or more of the pressure safety valve kits included in this field correction. Description of the product - The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: " Gravity - designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. " Prevacuum - designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer. Description of the problem - STERIS has identified that a small number of preventive maintenance kits for the Eagle 3000 Small Sterilizer were assembled with a I 00 psig safety valve instead of a 40 psig valve, potentially resulting in the JOO psig valves being installed on sterilizers in the field. Use of the incorrect valve could result in the improbable scenario of water and steam leaking from the unit's fittings, or accumulation of steam in the chamber. STERIS has not received any reports of adverse events related to the issue described above. STERIS Action - A STERIS Service Technician will contact your facility to inspect your unit(s), and repair if necessary. User Action - STERIS requests users inspect their affected unit(s) to verify which valve is installed. The valve ca
Worldwide distribution - US Nationwide distribution in the states of AL AR AZ CA CO DE FL GA HI IA ID IL IN KS LA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV, and country of Canada.
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