Date Initiated by Firm |
May 23, 2007 |
Date Posted |
August 09, 2007 |
Recall Status1 |
Terminated 3 on May 25, 2010 |
Recall Number |
Z-1073-2007 |
Recall Event ID |
37999 |
510(K)Number |
K052135
|
Product Classification |
Ultrasonic Lithotripter - Product Code FFK
|
Product |
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
|
Code Information |
Product distributed prior to May 7, 2007. |
Recalling Firm/ Manufacturer |
Gyrus ACMI Corporation 136 Turnpike Road Southborough MA 01772-2118
|
For Additional Information Contact |
508-804-2600
|
Manufacturer Reason for Recall |
Sterilization Instructions not adequate for sterilizing.
|
FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
53 units |
Distribution |
Nationwide and Canada. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FFK and Original Applicant = CYBERSONICS, INC.
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