Recall Z-1320-2023— Biosense Webster, Inc.

Name: FDA recall Z-1320-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-21

Class II · Ongoing

Class II FDA medical device recall by Biosense Webster, Inc., initiated 2023-02-21. It names one FDA 510(k) clearance: K170997. Product: 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.

Recalling firm: Biosense Webster, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-21
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc.·cleared 2017-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.