Kalila Medical recalls Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inse…

Recall date

December 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0564-2018

FDA classification

Class II

Brand / firm

Kalila Medical

Sold / distributed

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.

Why it was recalled

Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.