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Stryker Issues Class 1 Recall Following Death of Patient

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Stryker, the Kalamazoo, Michigan, based device manufacturer, issued a Class 1 recall of their Neptune Fluid Waste Removal Systems. The initial recall of the device in early June was issued to alert hospitals and physicians that the waste removal systems should not be connected to passive drainage tubes. In one case, a patient’s passive drainage tube had been connected to the Neptune 2 system and the patient died.

September 18, the company expanded its recall to the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra waste removal system, because the waste removal systems apparently did not have prior approval by the U.S. Food and Drug Administration (FDA) to be marketed until their safety and effectiveness could be determined.

Stryker has halted distribution of the waste removal systems. According to an article in BusinessWeek, September 25, 2012, the company says, "Customers who do not have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices" and should request a certificate of medical necessity if they plan to continue using them."

Some "customers" (patients?) may not have a viable choice.