Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray
This recall has been terminated (originally issued August 9, 2007).
- Company
- Gyrus Acmi Corporation
- Recall Initiated
- May 23, 2007
- Posted
- August 9, 2007
- Terminated
- May 25, 2010
- Recall Number
- Z-1073-2007
- Quantity
- 53 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterilization Instructions not adequate for sterilizing.
Distribution
Nationwide and Canada.
Lot / Code Info
Product distributed prior to May 7, 2007.
Root Cause
Other
Action Taken
Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.