BEUDAMED
    FDA Recall Terminated

    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.

    Recall: Z-1715-2015 · Initiated May 11, 2015

    Recall

    Recall Number
    Z-1715-2015
    Event Number
    71209
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    FEB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 11, 2015
    Posted
    June 5, 2015
    Terminated
    July 6, 2016
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.

    Reason

    Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.

    Action

    A customer notification letter dated 5/7/15 will be sent to all customers on 5/13/15 to inform them that ASP is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels and subsequently pass the cycle without cancellation if there is a disconnected scope. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 888-879-8144. Customers with questions regarding the business reply card are instructed to contact Stericycle at 888-345-4671 and reference event #7781.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.

    Quantity

    44 units