Recall Z-2449-2008 ยท HRX Arthroscope
Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Single Suction. Catalog # 7211005. Bag is used for remote in a sterile field.
| Date | Sep 21, 2008 (initiated Aug 7, 2008) |
| Status | Terminated |
| Reason | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
| Root cause | 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 | 3,222 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM Smith & Nephew, Inc., Jun 15, 2005 |