Steris Caviwave Pro Ultrasonic Cleaning System Recalled for Power Failure Risk
Steris is recalling 491 Caviwave Pro Ultrasonic Cleaning Systems because a power interruption may stop the pump and generator without alerting the user.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Steris Corporation is recalling 491 units of the Caviwave Pro Ultrasonic Cleaning System. The device is used to wash or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization. The recall covers units distributed worldwide, including in the United States and several international countries, between December 20, 2010, and February 18, 2015.
The recall is due to a potential malfunction where a temporary interruption in electrical power during a processing cycle may cause the circulation pump and ultrasonic generator to stop functioning. The device does not provide an alert to notify the user of this malfunction, which could result in instruments not being properly cleaned or dried.
Healthcare facilities and users should stop using the affected devices and contact Steris Corporation for further instructions on repair or replacement.
The recalled product
- 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.
- Manufacturer
- Steris Corporation
- Affected units
- 491
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units distributed between 12/20/2010 and 02/18/2015
Distribution
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