Recall Z-1105-2007 ยท DWQ Stripper, Vein, External
Smith & Nephew, Inc Endoscopy Division
Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
| Date | Aug 2, 2007 (initiated Oct 12, 2004) |
| Status | Terminated |
| Reason | Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery. |
| Root cause | Other |
| Action | Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement. |
| Quantity | 274 units. |
| Distribution | Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032387 | TRIVEX SYSTEM Smith & Nephew, Inc., Oct 29, 2003 |