Recall Z-2700-2020— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2020-06-26, terminated 2020-12-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-26
- Terminated
- 2020-12-22
- Firm location
- Mentor, OH, United States
Product description
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.
Reason for recall
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Data sourced from openFDA. This site is unofficial and independent of the FDA.