FDA Update: Agency Recalls Getinge CARDIOHELP Emergency Drive

The U.S. Food and Drug Administration (FDA) announced on Dec. 8 that Getinge is recalling the CARDIOHELP Emergency Drive due to an impaired or inability to turn the drive.

According the FDA, "the emergency drive can become stuck or difficult to turn due to friction being generated in the handle attachment." The device is used to help oxygenate and remove carbon dioxide from blood.

The agency has identified this as a Class I recall, indicating it is the most serious type of recall where use of these devices may cause serious injury or death. For more information and recommendations, access the FDA website.

Keywords: ACC Advocacy, United States Food and Drug Administration, Oxygenators

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