Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Summary
The FDA issued a Class II for Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D by Biosense Webster, Inc.. Reason: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match .
Details
Source
Device Recall
External ID
Z-1320-2023
Action Date
2023-04-12
Status
Ongoing
Category
device
Product Description
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Lot/Code Info: Lot # 50000224; UDI (GTIN) : 10846835016277
Quantity Affected: 316 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-21
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biosense Webster, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biosense Webster, Inc. have FDA actions?
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1320-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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