—#135440

Product

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.

FDA product code: MDZ — Cleaners, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All units distributed between 12/20/2010 and 02/18/2015

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-02-19
Posted by FDA: 2015-04-30
Terminated: 2015-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.