Stryker stopped manufacturing the Neptune 1 Silver device in 2009 but still provides support. The FDA emphasized that the new warning does not apply to those products. Under Stryker's earlier recall, customers who had bought the firm's Neptune 1 Gold Rover (regular and international), Neptune 1 Bronze, and Neptune 2 Rover Ultra were issued warning labels with many of these revisions. Instead, the regulator is instructing customers with these devices not to use them unless they have no alternative systems for collecting and disposing of surgical fluid wastes.įor customers who find it necessary to continue using the recalled systems, the FDA and Stryker issued a series of detailed instructions and warnings.įor example, they said, customers should verify that they "are using the intended units of measure when setting suction levels," because the digital readouts can be in inches of mercury, millimeters of mercury, or kilopascals.Ĭustomers were also told to ensure that suction is not set to higher levels than necessary for a given application, and under no circumstances should either device be used for respiratory tract suction. market due to concerns that removal would likely create immediate market shortages." But the FDA determined that the Neptune 1 Silver and Neptune 2 Ultra models also contained modifications that should have been submitted for premarket 510(k) notification, which Stryker had not done.ĭespite the violation, the agency said, "the FDA is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. However just above it are some really nice bathrooms, if you are needing to use one. It is tucked away in a corner and super easy to miss. Previously, Stryker had issued revised labeling for these and four other models in the Neptune 1 and Neptune 2 lines. 2 reviews of Neptunes Fountain 'For being the Roman God of the Sea, Neptune gets a very small fountain. "When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle and vital organ damage that can lead to serious injury and/or death." "The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action," the FDA said. Details of the other, nonfatal injury were not disclosed. According to Stryker, the fatality occurred when a customer connected the Neptune 2 system to a patient's chest drainage tube after surgery.
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