FDA: Class I recall of Agilis Steerable Reprocessed Introducer Sheath
Editor's Note
The Food and Drug Administration (FDA) on January 2 classified the recall by Sterilmed (Plymouth, Minnesota) of its Agilis Steerable Reprocessed Introducer Sheath as Class I, the most serious.
The sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail because of an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or create a pressure difference that lets air into the circulatory system (air embolism).
The recall includes all product lots and model numbers STJ408309, STJ408310, and STJG408324. Manufacturing and distribution dates were January 1 to May 5, 2017.
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
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