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FDA Slaps Lumenis Ltd. (LUME) Recall With Class I Status


2/26/2013 8:59:33 AM

The FDA designates the recall of Lumenis Ltd.'s VersaCut morcellator as Class I, its most serious level. The FDA slapped the recall of the Lumenis VersaCut tissue morcellator with Class I status, denoting a device that can cause serious injury or death. Morcellators are used to cut and remove large masses of tissue during laparoscopic procedures. Yokneam, Israel-based Lumenis is pulling the devices due to a labeling problem that could lead to "serious adverse health consequences, including death," according to the FDA. "Lumenis Ltd. is recalling certain models of VersaCut morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing," according to the federal watchdog agency.

Read at MassDevice


   

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