—#51066

Product

Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.

FDA product code: DWQ — Stripper, Vein, External
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K032387
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc Endoscopy Division
Address: 76 S. Meridian Ave, Oklahoma City, Oklahoma 73107-6512

Distribution

Distribution pattern: Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.

Timeline

Recall initiated: 2004-10-12
Posted by FDA: 2007-08-02
Terminated: 2007-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51066. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.