FDA-Device2023-04-12Class II
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Biosense Webster, Inc.
Hazard
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
Sold states
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.
Affected count
316 units
Manufactured in
31 Technology Dr Ste 200, Irvine, CA, United States
Products
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2023Don't want to check this manually?
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