The U.S. Food and Drug Administration (FDA) recently issued a Class I Recall for the Reprocessed Agilis Steerable Introducer Sheath by Sterilmed due to improperly sealed sheath hubs. An improper seal can allow blood to leak through the hub, which may cause the cap to detach during the procedure or create a change in pressure that lets air into the circulatory system. Use of affected products may cause serious health consequences, including death. The recall includes all product lots for model numbers STJ408309, STJ408310 and STJG408324 manufactured and distributed Jan. 1 – May 5, 2017.

The FDA recommends health care facilities and providers examine their inventories and stop using affected products immediately. Providers should continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal. Read the full recall notice here.

Keywords: United States Food and Drug Administration, Fibronectins, Alkaloids, Cardiovascular System, ACC Advocacy

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