4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514
FDA device recall Z-1228-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
- Action taken
- Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 5553 units/Expanded 1488 units
- Distribution
- Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
- Date initiated
- 2006-06-19
- Date posted
- 2006-07-13
- Date terminated
- 2008-01-10
- 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 |
|---|---|---|
| DYONICS VARICOSE VEIN ABLATION BLADE (K990723) | Smith & Nephew, Inc. | 1999-10-05 |