Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Reported: April 12, 2023 Initiated: February 21, 2023 #Z-1319-2023
Product Description
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-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
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile. Recalled by Biosense Webster, Inc.. Units affected: 277.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1319-2023.
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