FDADecember 14, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
kalila medicalkalila
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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