EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes.
FDA Recall Z-0965-2017 · Posted 2017-01-09
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Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFEB
Date Initiated2016-09-27
Date Terminated2017-04-17
Product Quantity107 units
Reason for Recall
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Firm Action
ASP has sent out Service Representatives to all impacted customers to inspect the hoses for the EVOTECH Endoscope Cleaner and Reprocessor System and will replace the hose if required.
The firm issued a Technical Bulletin dated 8/22/2016. Customers were instructed to complete online training prior to performing the actions described in the bulletin and follow instructions.
For orders and questions call 888-783-7723 or email: [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K152189EVOTECH ECRAdvanced Sterilization Products (Asp) · 2016-07-20K082392EVOTECH ENDOSCOPE CLEANER AND REPROCESSORAdvanced Sterilization Products · 2008-11-13K061889BIOSTAR OIA SHIGATOXInverness Medical-Biostar, Inc. · 2006-12-12K040883EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEMAdvanced Sterilization Products · 2005-03-15
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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