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.
Recall
- Recall Number
- Z-0965-2017
- Event Number
- 75290
- Firm
- Advanced Sterilization Products
- FEI Number
- 3003662624
- Product Code
- FEB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 27, 2016
- Posted
- January 9, 2017
- Terminated
- April 17, 2017
- Address
- 33 Technology Dr, Irvine, CA, 92618-2346
Description
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.
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
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].
US Nationwide Distribution.
107 units