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U.S. Department of Health and Human Services

Class 2 Device Recall Vision MultiChamber Washer/Disinfector

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 Class 2 Device Recall Vision MultiChamber Washer/Disinfectorsee related information
Date Initiated by FirmApril 10, 2023
Date PostedMay 17, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1595-2023
Recall Event ID 92044
Product Classification Disinfector, medical devices - Product Code MEC
ProductReliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Code Information UDI-DI: 00724995193164; Serial Numbers: 3600416016 3604417032 3608519001 3616109004 3624018002 3629014002 3633013003 3600622024 3604520026 3608615002 3616111012 3624210004 3629108006 3633206001 3600714004 3604612002 3609014014 3616113019 3624521001 3629112001A 3633317002 3600908001 3604710009 3609207002 3616318001 3624616022 3629119023 3633319035 3600908011 3605009011 3609422016 3616320002 3624812020 3629217002 3633321010 3601011012 3605013002 3609512007 3616914006 3624919019 3629420002 3633511005 3601014015 3605015001 3609809008A 3616918017 3625010007 3629711013 3633514038 3601017002 3605219005 3609814014 3617007001 3625114031 3629719006 3633515002 3601210008 3605312002 3609819030 3617009001 3625213015 3629921003 3633515004 3601215025 3605317002 3610007005 3617219002 3625220019 3630214002 3633520032 3601414005 3605411007 3610108008 3617310007 3625321002A 3630218043 3633609012 3601822001 3605510007 3610113001 3617414019 3625412018 3630320001 3633613033 3602108001 3605514027 3610312006 3617516021 3625518003 3630419006 3633707001 3602108005 3605715001 3610614003 3617520001 3625611009 3630511006 3633718036 3602110011 3605809011 3611115001 3618021027 3626009006 3630617003 3633813008 3602114001 3605814002 3611208008 3618407005 3626119006 3630618025 3634010002 3602213002 3606012003 3611222002 3618419005 3626120002 3630716003 3634019028 3602323012 3606110010 3611507014 3618506004 3626217001 3630921002 3634111014A 3602411012 3606111003 3611512001 3618517001 3626410001 3631006005A 3634116003 3602511011 3606117003 3611618001 3618709008 3626611005 3631019002 3634421001 3602512001 3606216001 3611709005 3618915003 3626621028 3631212002 3634608008A 3602517002 3606319035 3611717001 3618919003 3626719002 3631216030 3634707001 3602609007 3606414002 3611915001 3619020001 3626807001 3631217002 3634914028 3602714001 3606415003 3612318005 3619108006 3626912007 3631415002 3635313002 3602822001 3606416009 3613309009 3619312002A 3627210004 3631420028 3635820001 3602915001 3606712001 3613514002 3619509001 3627220001 3631513032 21361632135 3603014002 3606712003 3613713002 3619514016 3627314008 3631514002 980000005982 3603111001 3606717002 3614214002 3619615001 3627319043 3631709004 980000006284 3603117002 3606718005 3614318001 3621815016 3627517039 3631712023 980000006290 3603316002 3606722001 3614408006 3622413006 3627611013 3631719003 980000006291 3603420039 3606816007 3614715002 3622515004 3627612004 3631817002 980000006292 3603514019 3606914022 3614814010 3622620001 3627708005 3631916033 980000006293 3603615002 3607019041 3614909001 3622711006 3627718004 3632006004A 980000006294 3603817002 3607115001 3615022012 3622810002 3627721008 3632120029 980000006295 3603910011 3607217034 3615117002 3622812008 3627809004 3632213019 980000006332 3603912002 3607314001 3615216002 3622916001 3627817004 3632216004 980000006453 3603918005 3607411010 3615306011 3623014002 3628011011 3632221028 980000006458 3604114026 3607509011 3615311007 3623113010 3628019040 3632314002 980000006459 3604120029 3607616001 3615413018 3623308004A 3628110011 3632319002 980000006474 3604209012 3607620030 3615514008 3623412001 3628320001 3632610003 980000006475 3604219042 3607813001 3615618001 3623412001A 3628412002 3632812002 980000006498 3604222002 3607915001 3615717002 3623419003 3628419027 3632820027 980000006500 3604308012 3608022914 3615816011 3623510006 3628518014 3632914002 980000006502 3604313001 3608112002 3615819027 3623516024 3628621001 3632915001 980000006503 3604315005 3608116012 3616016002 3623521012 3628709002 3632916002 980000006546 3604414001 3608414012 3616017019 3623820001 3629011014 3632919037 980000006853
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactSteris Customer Service
800-548-4873
Manufacturer Reason
for Recall		In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE FIELD CORRECTION dated 3/28/23 was sent to customers. STERIS Action: All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) to perform the correction. User Action: Users can continue to use their Reliance Vision Multi-Chamber Washer/Disinfector prior to completion of the correction. Should your unit alarm Drying Temperature Too High, abort the cycle, turn off the power to the unit, and contact STERIS. The competent (regulatory) authority of your country has been informed of this notice. Customer response is not required. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Senior Product Manager at 440-392-7571, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Quantity in Commerce322 units
DistributionWorldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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