Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

Reason: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

Code information: Lot # 50000224; UDI (GTIN) : 10846835016277

Distribution pattern: Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.