September 27, 2012 — The medical device company Stryker Corp. is expanding a Class 1 recall of Neptune Waste Management Systems after one death was reported. The devices were sold without formal clearance from the U.S. Food and Drug Administration (FDA). The fatal incident occurred when a patient’s passive chest tube was hooked up to a high-powered, high-volume vacuum used to suck up waste fluid during surgery. The Neptune lacks warnings about attaching the device to a passive chest tube.
The Class 1 recall was initiated in June 5, following two reports of serious injury, including the one patient who died. On September 18, Stryker expanded the recall to include the Neptune 1 Silver, the Neptune 2 Ultra, and a more powerful Neptune 2 Ultra because the products lack FDA approval.
The FDA does not consider the devices “to be legally marketed because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”
The FDA is also asking Stryker to obtain 510(k) clearance before they are allowed to market or sell the devices. Without approval, “FDA is therefore unable to determine whether these devices are as safe or effective as their legally marketed predicate.” A 510(k) application allows approval of new devices that are “substantially equivalent” to existing devices, and the manufacturer does not need to conduct additional safety testing.
Stryker has not recalled all of its waste management systems. Customers with the Neptune 1 Gold, Neptune 1 Gold International, or Neptune 1 Bronze will receive a mailing in October that contains updated warning labels and new instructions for how to use the device safely.
The FDA and Stryker are recommending that customers who own one of the recalled Neptune Waste Management Systems should stop using it. However, customers who have no alternative devices should weigh the risks and benefits of continuing to use the recalled devices. Customers who wish to continue using the recalled devices must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012. Stryker will send these customers warning labels and instructions.
The Neptune Waste Management System is a medical device used to collect and dispose surgical waste in the operating room. This limits exposure of healthcare workers to bodily fluids and splash exposure during surgery. The closed system also reduces the solid waste disposal costs and eliminates excessive handling of surgical waste.
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