Events

Recall of Device Recall EVOTECH Endoscope Cleaner and Reprocessing System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71209
  • Event Risk Class
    Class 2
  • Event Number
    Z-1715-2015
  • Event Initiated Date
    2015-05-11
  • Event Date Posted
    2015-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136592
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, cleaning, for endoscope - Product Code FEB
  • 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.

Device

Device Recall EVOTECH Endoscope Cleaner and Reprocessing System
  • Model / Serial
    5040207003 5040207004 5040308003 5042100008 5042100016 5042100017 5042100018 5042100019 5042100020 5042100021 5042100022 5042100023 5042100024 5042100025 5042100033 5042100034 5042100035 5042100036 5042100037 5042100038 5042100039 5042100040 5042100060 5042100061 5042100063 5042100064 5042100065 5042100066 5042100067 5042110002 5042110003 5042110004 5042110005 5042110006 5042120002 5042120006 5042130009 5042130011 5042140029 5042140030 5042140031 5042140032 5042140038 5042140039
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
  • Product 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.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA