CARTO VIZIGO Bi-Directional Guiding Sheath recall
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and…
Why was CARTO VIZIGO Bi-Directional Guiding Sheath recalled?
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
- Product
- CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and…
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 853 units
- Distribution
- U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)