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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO Eagle 3000 Sterilizer

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  Class 2 Device Recall AMSCO Eagle 3000 Sterilizer see related information
Date Initiated by Firm October 22, 2019
Create Date December 05, 2019
Recall Status1 Terminated 3 on May 06, 2020
Recall Number Z-0604-2020
Recall Event ID 84185
510(K)Number K964332  
Product Classification Sterilizer, steam - Product Code FLE
Product 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.
Code Information Product Serial Numbers: 11729306 R813159712 R832721203 12539208 R812130301 R811500201 R812179701 R813490404 13469106 R813510301 11349304 R812689903 R812430409 13399103 R810790402 100981005 R812629901 106978007 R832880701 R810120405 R812789806 R811830206 R813500402 R810629201 R811050302 R812439601 R832291101 13369306 104286006 R813020412 R812360406 R831140901 101085003 R831380701 R813210405 R810410302 R833420901 R812820601 R810350503 R810140502 R812050102 R831391002 R833220902 12448403 R810290504 R813450203 11029301 R810819305 R813539903 10319205 R810580403 R1683042006 R812379902 107887005 R811730502 R811829803 10079311 R810590201 R810210203 R811540503 R812599701 R811490303 R810570201 10219406 R812430502 R812280003 R811310001 10219310 10459406 R812530502 12929207 R810089901 R832791102 10359401 R811110501 R831740901 R811760202 128887017 10459408 R810550502 10369307 10599202 130187010 10309307 R810740501 R810569302 10019309 105185002 R812930301 R813410501 10849312 107080008 132387005 R811690211 R813410502 11239318 106880005 110686003 R813330001 11298909 R811460405 10949203 R812330602 R810870601 13299213 R812290605 10919208 R813190104 R813349502 R812780503 R812559801 R811370104 10299103 R830271201 R810950607 R831730801 10859201 10389102 R811049906 13149002 R812629204 R811370103 13179211 11149202 R811570601 R811050303 R810029702 12819205 11119205 R810670602 R811550403 R830370702 12749205 11129204 109783015 R812490104 10449306 R831561001 11049203 R831370701 13239203 12299303 R831521001 11439120 R831650702 11169410 R811980101 106585015 11309303 R810770203 12679203 R812570107 R812769701 R811240001 R810669607 10449304 R812570108 R812969401 13099205 R810119905 13219410 R811400212 R812819402 12949203 R832190701 R812099802 12959004 R811989501 R811790503 13019214 12729303 13549211 R831860802 R812020501 R813370405 R812989905 R813250109 R812109713 10549307 R811320302 R812350105 11269307 R812169704 10639305 R813280401 R812079001 R813570402 R810390208 R810690306 R831860801 R810350502 R833400801 R812740402 R811760203 R832260804 R810490502 R810629802 R813100205 R812860306 R831870801 10019310 34338 R812520201 R813030201 9977420 990212 10429201 R810710201 R811760305 R831120801 117716SAW R812630003 R810239601 R812040303 R810610602 R832120701 R811269901 R830891201 R812610304 R833491102 R813489810 R811700306 R811300002 R812660301 R833111101 10569310 R812640001 12289203 R812610303 R813450202 R812669303 13579210 12479209 R812600407 R811619708 101680009
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact
440-392-7601
Manufacturer Reason
for Recall		 Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
FDA Determined
Cause 2		 Packaging
Action 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
Quantity in Commerce 236
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = AMSCO INTL., INC.
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