DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005
FDA device recall Z-2077-2009 · posted 2009-09-21 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- The sterility of the device cannot be assured
- Action taken
- Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 67,697 units
- Distribution
- Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, P
- Date initiated
- 2009-05-27
- Date posted
- 2009-09-21
- Date terminated
- 2012-05-08
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM (K051326) | Smith & Nephew, Inc. | 2005-06-15 |