Events

Recall of Device Recall EvoTech Endoscope Cleaner & Reprocessor

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
    46906
  • Event Risk Class
    Class 2
  • Event Number
    Z-1368-2008
  • Event Initiated Date
    2008-02-13
  • Event Date Posted
    2008-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68457
  • 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
    Endoscope Washer/Disinfector - Product Code FEB
  • Reason
    Cleaning cycles are being cancelled. specific issues are: a) water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) interface board malfunction resulting in a premature lid opening, and c) minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
  • Action
    Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.

Device

Device Recall EvoTech Endoscope Cleaner & Reprocessor
  • Model / Serial
    Product Code 50004; Serial Numbers: 50004001070080, 50004001070082, 50004001070083, 50004001070043, 50004001070044, 50004001070046, 50004001070048, 50004001070023, 50004001070024, 50004001070021, 50004001070075, 50004001070045, 50004001070078, 50004001070079, 50004001070107, 50004001070110, 50004001070081, 50004001070062, 50004001070064, 50004001070063, 50004001070034, 50004001070025, 50004001070029, 50004001070047, 50004001070049, 50004001070061, 50004001070087, 50004001070088, 50004001070084, 50004001070077, 50004001070076, 50004001070085, 50004001070086, 50004001070090, 50004001070091, 50004001070094, 50004001070089, 50004001070092, 50004001070098, 50004001070097, 50004001070099, 50004001070100, 50004001070101, 50004001070105, 50004001070106, 50004001070108, 50004001070109, 50004001070102, 50004001070103, 50004001070104, 50004001070020, 50004001070031, 50004001070035, 50004001070036, 50004001070039, 50004001070042, 50004001070059, 50004001070065, 50004001070071, 50004001070072, 50004001070073, 50004001070074, 50004001070114
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada and Japan.
  • Product Description
    EvoTech Endoscope Cleaner & Reprocessor, Product || Code 50004 || Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive 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