Z-1320-2023 Class II Ongoing
FDA device recall Z-1320-2023 was initiated by Biosense Webster, Inc. on February 21, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 316 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- February 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 316 units
Product Description
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Reason for Recall
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
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.
Code Information
Lot # 50000224; UDI (GTIN) : 10846835016277