Events

Recall of Device Recall Caviwave Pro Ultrasonic Cleaning System

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

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
    70899
  • Event Risk Class
    Class 2
  • Event Number
    Z-1559-2015
  • Event Initiated Date
    2015-02-19
  • Event Date Posted
    2015-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135440
  • 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
    Cleaners, medical devices - Product Code MDZ
  • Reason
    Should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. in addition, it is possible that the ultrasonic generator may stop working. the machine does not provide an alert notifying the user of this device malfunction.
  • Action
    STERIS sent an Urgent Field Correction Notice letter dated March 9, 2015 customers. The letter identified the description of the product, description of the problem and actions to be taken. For questions contact STERIS Customer Service at 1-800-548-4873 or local sales representative.

Device

Device Recall Caviwave Pro Ultrasonic Cleaning System
  • Model / Serial
    All units distributed between 12/20/2010 and 02/18/2015
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH,NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and the countries of: Australia, Brazil, Canada, France, Mexico, Saudi Arabia, Spain, Taiwan & United Arab Emirates.
  • Product Description
    Caviwave Pro Ultrasonic Cleaning System, || Product Usage: || To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA