The U.S. Food and Drug Administration (FDA) announced the recall of Stryker Corp.’s Neptune Waste Management Systems due to serious injuries caused by the devices.
What Are Stryker Neptune Waste Management Systems?
Stryker’s Neptune Waste Management Systems are high flow, vacuum-powered devices that remove liquid waste products and smoke produced during surgical procedures. One of their primary virtues is handling surgical waste without causing splashing or exposing health care workers to hazardous biological materials.
Stryker Neptune Waste Management Systems Have Been Recalled
On September 25, 2012, the FDA classified Stryker’s decision to recall Neptune Waste Management Systems on June 5, 2012 as a class I recall. Stryker justified its actions on two reports of serious injuries caused by the devices, including one fatality that occurred when the device was attached to a passive chest drainage tube post-operation. Stryker admitted that its documentation for the devices did not warn medical professionals not to connect the vacuum device to a passive drainage tube.
The recall affects Neptune Waste Management devices sold in the United States, Canada, Latin America, Japan, Asia Pacific, and Europe, and it includes the following six products:
- Neptune 1 Gold Rover
- Neptune 1 Gold Rover – International
- Neptune 1 Silver Rover
- Neptune Bronze
- Neptune 2 Rover Itra (120 V)
- Neptune 2 Rover Ultra (230 V)
The recall originally applied to the Neptune 1 Gold, Neptune 1 Gold International, and Neptune Bronze, and Stryker sent new warning labels to owners. Subsequently, the FDA informed Stryker that the remaining three devices had not been approved through its 510(k) premarket approvals process, so the agency does not advise health care providers to use them unless they have no alternative and have weighed the potential risks against the potential benefits and have submitted a Certificate of Medical Necessity to Stryker. Stryker will discontinue sales of the devices pending FDA approval, and it will mail safety instructions to customers that continue using the devices and have sent certificates.
Class I recalls are the most serious kind of recalls because there is “a reasonable probability that use of the product will cause serious adverse health consequences or death.”
RLG’s Neptune Waste Management Systems Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Neptune Waste Management Systems lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Neptune Waste Management Systems lawsuit on your behalf if necessary. RLG will also keep you up to date on any Neptune Waste Management Systems class action lawsuits, FDA Neptune Waste Management Systems warnings, and additional Neptune Waste Management Systems FDA recall announcements. If you believe a Neptune Waste Management System harmed you during surgery, contact RLG today.