Reuters: Regulatory News: UPDATE 1-Stryker widens recall of surgical waste management line

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UPDATE 1-Stryker widens recall of surgical waste management line Sep 25th 2012, 19:35 Tue Sep 25, 2012 3:35pm EDT Sept 25 (Reuters) - Stryker Corp said on Tuesday it expanded the recall of its Neptune surgical waste management product line to include later versions because U.S. health authorities have advised the company that these devices do not have proper regulatory clearance. In June, the company issued a Class 1 recall, the most serious type, of its Neptune waste system after receiving two reports of serious injury and a fatality resulting from the use of the product. The device collects surgical waste in the operating room and then disposes of the fluids without ever exposing healthcare workers to the waste. Stryker also notified customers that it was recalling the instructions for use because they did not specifically warn against connecting the high vacuum/high flow device to a passive drainage tube. In a press release, Stryker, a maker of hospital beds and orthopedic implants, said the U.S. Food and Drug Administration is unable to determine whether these last-generation devices are as safe and effective as their legally marketed predecessor, the Neptune 1. The recall affects the following products: Neptune 1 Gold Rover; Neptune 1 Gold Rover - International; Neptune 1 Silver Rover; Neptune Bronze; Neptune 2 Rover Ultra (120 V); and Neptune 2 Rover Ultra (230 V).

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