Class I Recall for Neptune Rover Waste Management System
The Food and Drug Administration (FDA) and Stryker Corp. extended a Class I recall of Neptune surgical waste removal systems issued earlier this year after the devices caused two cases of serious injury, including one death.
A Class I warning is issued by the agency when there is the potential for a product to cause serious health problems or death.
M Live reports that the initial Neptune product liability recall focused on changing the label instructions to advise that the high-vacuum, high-flow device should never be hooked up to a patient’s passive drainage tube.
Last week, Stryker notified customers via letter that it is expanding that recall to include the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because the FDA has advised Stryker that the devices do not have regulatory clearance and their safety and effectiveness is yet to be determined by the agency.
The FDA said that the devices should not be used until the agency approves them. However, health care providers without an alternative device can complete a certificate of medical necessity and return it to the company by Oct. 12, according to M Live.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you.