Biosense Webster, Inc.: CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac

Hazard

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Details from the source

Reason for recall: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. 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. Quantity: 853 units Lot/code info: Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282

UPC codes

10846835016277

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.