Stryker Waste Management System Recalled After Injuries, Death
Reports of two serious injuries, including one fatality, prompted Stryker to issue a Class I recall of the Neptune Waste Management System. The recall includes the Neptune 1 Gold Rover, Neptune 1 Silver Rover, Neptune Bronze Rover, Neptune 2 Rover Itra and Neptune 2 Rover Ultra. The systems were recalled because their labeling did not specifically warn not to connect the high-vacuum/high-flow devices to passive drainage tubes, and the patients were harmed when caregivers made such connections. The GMP Letter
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
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