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Stryker Recalls Neptune Devices After Death Reported – Bloomberg.

Stryker Recalls Neptune Devices After Death Reported

By Michelle Fay Cortez – Sep 26, 2012 6:18 AM ET
Stryker Corp. (SYK) stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.

Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died, Stryker said.

The initial recall was intended to inform customers that the devices shouldn’t be connected to passive drainage tubes, a warning that wasn’t on the label. The company extended the recall on Sept. 18 to inform customers that the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra don’t have U.S. Food and Drug Administration approval.

The FDA doesn’t consider the devices “to be legally marketed devices because their safety and effectiveness have not yet been determined,” the company said in the statement. “As such, FDA advises that the devices not be used.”

Stryker stopped distributing the devices. Customers who don’t have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices and request a certificate of medical necessity if they plan to continue using them, the company said.

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