FDA-Device2020-08-05Class II
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
Steris Corporation
Hazard
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.
Affected count
1283
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2700-2020Don't want to check this manually?
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