Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry lap
FDA device recall Z-1559-2015 · posted 2015-04-30 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- STERIS sent an Urgent Field Correction Notice letter dated March 9, 2015 customers. The letter identified the description of the product, description of the problem and actions to be taken. For questions contact STERIS Customer Service at 1-800-548-4873 or local sales representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MDZ
- Quantity affected
- 491 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH,NJ, NM, NV, NY, OH, OK, OR,
- Date initiated
- 2015-02-19
- Date posted
- 2015-04-30
- Date terminated
- 2015-10-21
- Location
- Mentor, OH
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