On June 5, 2012, medical technology giant Stryker Co. recalled its Neptune Waste Management System nationwide after two patients were injured, one fatally, when using the devices. The company extended this recall on September 18, 2012, to inform consumers that the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra were never formally approved by the U.S. Food & Drug Administration (FDA). This is a Class I Recall, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product in question will cause serious adverse health consequences or death.
Stryker Neptune Waste Management System Update 3/12/13: This week, Stryker Orthopaedics received a warning letter from the FDA for failing to notify of a device recall and other quality system concerns. Specifically, the letter cites Stryker for failing to inform the FDA of a recall for the Neptune Waste Management System, and for marketing the device without 510(k) clearance. Click here to learn more.
Free Stryker Neptune Recall Lawsuit Evaluation: If you or a loved one was injured by a Stryker Neptune Waste Management System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Stryker Corp. and we can help.
What’s the problem?
The original Stryker Neptune recall was issued after two incidences of serious injury were reported from the devices, which are used to collect fluid waste during surgery. In one case, a patient died after their passive chest drainage tube was attached to the Neptune 2 System, a high-vacuum, high-flow device. The first recall was intended to inform both the public as well as the medical communities that Stryker Neptune devices should never be connected to passive drainage tubes, a warning that wasn’t on the label.
The FDA does not consider Neptune Waste Management Systems “to be legally marketed devices because their safety and effectiveness have not yet been determined,” Stryker said in a statement. “As such, FDA advises that the devices not be used.”
In response to the adverse events reported in connection with the devices, Stryker has discontinued the distribution of all Neptune Waste Management Systems affected by this recall. The company is advising patients who do not have an alternate machine available to carefully weigh the risks and benefits of the recalled devices before using them, and to request a certificate of medical necessity if they plan to continue using them.
Do I Have a Stryker Neptune Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Stryker Neptune recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Stryker Neptune Recall Lawsuit Evaluation: If you or a loved one was injured by a Stryker Neptune Waste Management System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a Stryker Neptune injury suit and we can help.