FDA Device

TriVex 100SV Resector Kit, 4.5 Part Number: 7205876

Hazard

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

What You Should Do

Remedy

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.

Products

TriVex 100SV Resector Kit, 4.5 Part Number: 7205876
Brand
Smith & Nephew, Inc. Endoscopy Division
UPC
Lot Numbers: All lot numbers lower than 50156094 Expanded recall:  Lot Numbers: 50172222, 50174786, 50174787, 50175045

Units Affected

8631 units/Expanded1071 units