Recall Z-1105-2007
Smith & Nephew, Inc Endoscopy Division · initiated October 12, 2004
Product
Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Codes / lots: Pnuematic Footswitch part of TRIVEX System with the following serial numbers: 105, 106, 108, 109, 111 -123, 125 - 182, 184 - 188, 192 - 197, 199 - 203, 205 - 219, 222 - 249, 252 - 254, and 7210386.
Reason for recall
Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1105-2007
- Initiated
- October 12, 2004
- Posted by FDA
- August 2, 2007
- Terminated
- August 2, 2007
- Product code
- DWQ – Stripper, Vein, External
- Quantity
- 274 units.
- Distribution
- Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK