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Stryker Receives FDA Warning Letter

Stryker Receives FDA Warning Letter

March 12, 2013 — Stryker Corp. has published a press release to announce that the U.S. Food and Drug Administration (FDA) has sent them a Warning Letter regarding poor quality control and improper marketing of medical devices. The FDA found quality control issues at a facility in Portage, Michigan during an inspection in November 2012. The FDA also cited Stryker for failing to inform them of a product recall, though Stryker did not specify which recall.

Stryker said that one improperly marketed device was the Neptune Waste Management System, which was recalled in 2012. The Neptune Waste Management Systems were sold without FDA approval. The FDA required a 510(k) approval, which allows new devices to be sold without clinical trials if they are “substantially equivalent” to another product that has been approved by the FDA.

In the Class I recall notice for the Neptune, the FDA warned:

“FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”

The products were recalled after two people were injured, one fatally, from improper use of the Neptune Waste Management System. The death occurred when the Neptune, a high-powered high-volume vacuum, was attached to a patient’s passive chest drainage tube post-operatively. The product lacked warnings about this risk.

According to the press release, Stryker announced they would be “fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.”

Do I have a Stryker Neptune Waste Management System Lawsuit?

The Schmidt Firm, PLLC is currently accepting medical device induced injury cases in all 50 states. If you or somebody you know has been injured by the Neptune Waste Management System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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