Device Recall Vado BiDirectional Steerable Sheath 8.8F

Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

Cardiovascular Devices

2

No

Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.

Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.