| Class 2 Device Recall DYONICS 25 Fluid Management System |  |
Date Initiated by Firm | August 07, 2008 |
Date Posted | September 21, 2008 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number | Z-2451-2008 |
Recall Event ID |
49132 |
510(K)Number | K051326 |
Product Classification |
Arthroscope. - Product Code HRX
|
Product | DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field. |
Code Information |
Lot Numbers:1458F, 1458J, and 1698J. |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
|
For Additional Information Contact | Pundit Tiwari 978-749-1073 |
Manufacturer Reason for Recall | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
FDA Determined Cause 2 | Packaging process control |
Action | Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008.
Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397. |
Quantity in Commerce | 4,044 units |
Distribution | Worldwide Distribution including USA and countries of Canada, Chile, Colombia, Greece, France, Australia, Netherlands, South Africa, United Kingdom, Japan, Dubai, Germany, India, Malaysia, Switzerland, Belgium, Italy, and Puerto Rico. |
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 = HRX
|
|
|
|