BEUDAMED
    FDA Recall Terminated

    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    Recall: Z-0628-2011 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-0628-2011
    Event Number
    57281
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    February 19, 2010
    Posted
    December 16, 2010
    Terminated
    July 30, 2013
    Address
    33 Technology Drive, Irvine, CA, 92618

    Description

    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    Reason

    The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a possible temperature monitoring system malfunction. This recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and resul

    Action

    Advanced Sterilization Products sent an URGENT: PRODUCT CORRECTION letter dated February 19, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall communication was initiated with ASP forwarding a "Urgent: Product Correction" letter with attached customer fax-back response form to the affected customers. Customers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435. If customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.

    Distribution

    Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria.

    Quantity

    1,881 units (1514 in US)