Stryker, the major medical device manufacturer, issued a Class I recall of their Neptune Fluid Waste Removal Systems in early June of this year. The initial recall was issued after two patients were injured and was meant to alert hospitals and doctors 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.
Just last week, the company announced that it would be expanding the recall to the Neptune 1 Silver, Neptune 2 Ultra and a high-powered Neptune 2 Ultra waste removal system. The reason is that none of the waste removal systems had proper prior approval by the U.S. Food and Drug Administration (FDA). As such, the devices should never have been marketed until their safety and effectiveness had been assured.
Stryker has taken action to stop all further distribution of the waste removal systems. According to Businessweek, the company had the following grave statements for patients: “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.”
The FDA has come out to say that the devices were not “legally marketed” and, as such, should not be used until they have been properly tested and formally approved by the regulatory agency.
We mentioned Stryker recently in a post about their neck stem recalls. The company has also been under fire thanks to a series of recalls for its Rejuvenate and ABG II hip implant devices. Just like the case involving the Neptune waste removal systems; these models were rushed through an abbreviated testing phase that did not permit proper time to rigorously test the devices. Stryker claimed the devices were “substantially similar” to previously approved devices and thus avoided further scrutiny.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please call contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
Source: “Stryker Recalls Neptune Devices After Death Reported,” by Michelle Fay Cortez, published at Businessweek.com.