Devices & Diagnostics

FDA classifies recall of a component of CareFusion’s Alaris infusion pump as Class I

The U.S. Food and Drug Administration classified the recall of  the PC unit of a […]

The U.S. Food and Drug Administration classified the recall of  the PC unit of a certain model of the CareFusion Alaris Infusion pump as Class I on Wednesday.

The Alaris PC unit model 8015 has a component that is causing error messages like “System Error” or “Missing Battery Error” at startup. On June 27, CareFusion (NYSE:CFN) sent a recall notification asking users to stop using the unit if either of the error messages were seen.

They were instructed not to return the device but to simply stop using the PC unit. The FDA classified the recall under Class I, its most serious category, because if the error code occurs during an infusion, programming changes cannot be made and that could lead to serious injury or death. If the error message occurs at startup, it could delay the start of therapy, the notification said.

[Photo Credit: Freedigitalphotos.net]

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