Recall Z-1319-2023 ยท DYB Introducer, Catheter
Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
| Date | Apr 1, 2023 (initiated Feb 21, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | On March 2, 2023, Biosense Webster, Inc. issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notification to affected US customers via FedEx. The notification was issued to foreign consignees on February 29, 2023. In addition to informing consignees about the recall Biosense Webster asked customer to take the following actions: 1. Carefully review the information contained in this Medical Device Correction/Removal. 2. Ensure that anyone in your facility who needs to be aware of this notification reads the attached letter carefully. 3. Evaluate if you have inventory of CARTO VIZIGO" Bi-Direc |
| Quantity | 277 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170997 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc., Jul 25, 2017 |