DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset.
FDA device recall Z-2448-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 11,469 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
- Date initiated
- 2008-08-07
- Date posted
- 2008-09-21
- Date terminated
- 2012-05-08
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM (K051326) | Smith & Nephew, Inc. | 2005-06-15 |