Recall Z-1559-2015— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2015-02-19, terminated 2015-10-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-19
- Terminated
- 2015-10-21
- Firm location
- Mentor, OH, United States
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.