Recall Z-1228-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Smith & Nephew, Inc. Endoscopy Division
4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514
| Date | Jul 13, 2006 (initiated Jun 19, 2006) |
| Status | Terminated |
| Reason | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device |
| Root cause | Other |
| Action | 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. |
| Quantity | 5553 units/Expanded 1488 units |
| Distribution | Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990723 | DYONICS VARICOSE VEIN ABLATION BLADE Smith & Nephew, Inc., Oct 5, 1999 |