After causing two serious injuries, including one death, Stryker Corp. is recalling the Neptune Waste Management System — a high-powered vacuum used during operations to suck up fluids. Several of these products lack FDA approval, and they all lack warnings about attaching the suction system to a patient’s passive drainage tube. The FDA is warning that healthcare workers should not use this device unless they have no alternative.
What You Can Do & How a Stryker Neptune Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Stryker Neptune induced injury cases in all 50 states. If you or somebody you know has been injured by a Stryker Neptune Waste Management System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is the Stryker Neptune?
Stryker Corp. manufactures several types of Neptune Surgical Waste Management Systems. The devices are used during operations to suck fluids out of a patient and dispose of the fluids safely. The system has a high-powered, high-volume vacuum, which sucks fluids into a disposal system. The disposal system limits the exposure of healthcare workers to splashing and handling of medical waste.
What is the problem?
There have been at least two serious incidents caused by improper use of the Neptune 2 Ultra Waste Management System. One incident involved the death of the patient. The device lacks warnings against attaching the vacuum to a patient’s passive drainage tube.
According to the FDA:
“When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.”
Stryker Neptune Recall
Stryker first issued a recall of the Neptune Waste Management System on June 5, 2012, and they received reports of injury and death. The recall was expanded on September 18, 2012, after an FDA investigation found that several Neptune systems were never approved before they were sold.
Stryker has cooperated with the FDA and issued a Class 1 recall — the most serious type of recall, which is only issued for device that have a good probability of causing severe injury or death. Click here to read the official recall notice.
The Neptune devices being recalled include:
- Neptune Waste Management System
- Neptune 1 Gold Rover (and International)
- Neptune 1 Silver Rover
- Neptune Bronze
- Neptune 2 Ultra (120 V)
- Neptune 2 Ultra (230 V)
FDA Warning for Stryker Neptune Surgical Waste Management System
The FDA published a Safety Communication on October 5, 2012. They warned:
“Healthcare providers should NOT use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available.”
Stryker Neptune Lacks FDA Approval
Three Stryker Neptune devices lack FDA approval and have been recalled: Neptune 1 Silver, Neptune 2 Ultra (120 V), and Neptune 2 Ultra (230 V). According to the FDA:
“At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”
The FDA has an approval system for new medical devices that are similar to existing, approved devices — it’s called the 510(k) approval process. A manufacturer does not need to conduct new safety studies, but they do need to gain FDA approval before they can legally market and sell their device in the U.S.
Do I have a Stryker Neptune Lawsuit?
The Schmidt Firm, PLLC is currently accepting Stryker Neptune induced injury cases in all 50 states. If you or somebody you know has been injured by a Stryker Neptune Waste Management System, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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