The U.S. Food and Drug Administration (FDA) issued a Safety Communication March 15, 2013, for two products made by Stryker Instruments medical technology company — the Neptune 1 Silver and Neptune 2 Ultra Waste Management System.
The medical instruments have been used to suction surgical fluid waste from patients in operating rooms and surgical facilities. Recent reports of serious tissue damage and a patient’s death prompted the FDA to send out the communication.
On June 8, 2012, the FDA initiated a Class I recall of the devices. Class I is the most serious and urgent recall the FDA can make. These recalls, the FDA says, “involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
U.S. customers using the devices (for example, directors of surgery, surgeons, and other operating room personnel) received Urgent Medical Device Recall Notifications through certified mail. International customers received the warning through email.
The FDA told the customers using the devices that if they had no alternative device, they could continue using the Stryker instruments if they completed a Certificate of Medical Necessity. The agency a week later issued a second safety communication saying that, “Only customers that complete the Certificate of Medical Necessity can use and will receive warning labels for the Neptune 1Silver and Neptune Ultra devices.
In September last year the FDA notified healthcare professionals of a Class I recall of the Stryker Neptune Rover Waste Management Systems in the U.S., Asia Pacific, Canada, Japan, Latin America, Europe, the Middle East, and Africa.
That same month, the FDA said it did not consider three of the Neptune devices (the Silver, the 2 Ultra, 210V, or the Ultra 230 V) to be on the market legally.
The safety and effectiveness of the instruments, the FDA said, have not yet been determined and they should not be used.
These devices are not on the market legally, according to the FDA, because they do not have 510K clearance. This type of FDA approval is given to medical devices that have met the same safety and efficacy standards as a device that has previous FDA approval.
The Institute of Medicine, one of the country’s most prestigious scientific groups, has said the 510K system should be abandoned and replaced because it fails to examine the safety and effectiveness of devices such as artificial hips before they go on the market.
The medical malpractice and product liability lawyers of Berkowitz and Hanna LLC represent injured patients throughout the state of Connecticut. If you or someone you love suffers serious injuries due to recalled medical devices, you can seek compensation by filing a claim. To learn more, contact our law firm today. We would be happy to answer any question.