Recall of Device Recall EVOTECH

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
    64781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1150-2013
  • Event Initiated Date
    2013-03-28
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-08-22
  • Event Source
    USFDA
  • Event Source URL
  • 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 they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the channel control manifold sub-assembly.
  • Action
    An Urgent Medical Device Field Correction letter dated 3/28/13 was sent to all customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR). The letter informed the customers of the problems identified and the actions to be taken. Customers are informed that the failure can potentially cause the following outcomes for the cycles listed below: 1. In the Full Reprocessing Cycle (Cleaning and HLD): there is a potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes. 2. In the HLD-Only Cycle: there is potential for an adequate amount of high-level disinfectant solution to be sent through some endoscope channels. If customers observe smoke, then they are instructed to: a. Power OFF the device. b. Report your incident to ASP Professional Services at (888) 783-7723 and select option #2. c. Do not use the device until it has been serviced by ASP. Customers are instructed to return attached buyer return card acknowledging their receipt of this communication. Customers are instructed to contact Stericycle at (866) 761-9566 for any questions related to the field correction.

Device

  • Model / Serial
    Batch 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. || Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
  • Manufacturer

Manufacturer

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