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Steris Corporation recalls InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STER
Recalled August 5, 2020 · FDA recall Z-2700-2020 · Steris
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. · FDA Class II
Units
1283
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.
Description
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Product
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.
Manufacturer(s)
Steris Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →