FDA-Device2017-01-18Class II
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 (>60¿C} semi-critical endoscopes.
Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Sold states
US Nationwide Distribution.
Affected count
107 units
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
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 (>60¿C} semi-critical endoscopes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2017Don't want to check this manually?
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