BRIEF-FDA Issues Class I Recall Of Reprocessed Agilis Steerable Introducer Sheath By Sterilmed

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2018-01-02 19:18:35

Jan 2 (Reuters) – U.S. Food And Drug Administration:

* U.S. FOOD AND DRUG ADMINISTRATION SAYS ISSUES CLASS I RECALL OF THE REPROCESSED AGILIS STEERABLE INTRODUCER SHEATH BY STERILMED

* U.S. FDA SAYS THE AGILIS STEERABLE INTRODUCER SHEATH’S HEMOSTATIC VALVE MAY FAIL DUE TO AN IMPROPER SEAL OF THE SHEATH HUB

* U.S. FDA SAYS USE OF THE AFFECTED PRODUCTS BY STERILMED MAY CAUSE “SERIOUS HEALTH CONSEQUENCES” FOR PATIENTS, INCLUDING DEATH Source text: (bit.ly/2DTRFq1) Further company coverage:

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