According to Ehline Law Firm PC – The distribution of the Neptune Systems have been halted and are being recalled by Stryker. The FDA advisory stated that they never cleared or approved the Neptune 1 Silver and Neptune 2 Ultra (120v and 230v) fluid waste management systems for sale in the U.S.
Neptune 1 Gold was approved, though the others have not been and the FDA said the safety and effectiveness is basically untested.
The FDA in a recall notice on September 25th advised owners of both the Neptune 1 and the Neptune 2 Ultra systems to stop use or do not use them, unless they have no fluid waste disposal alternative. They said that continued use of the devices, could have risks and users should weigh the risks and benefits associated with the device. The owners of these devices were told to submit a certificated of medical necessity to Stryker by October 12th.
This recall is an expansion on a June 5th recall, when the company issued a recall on the instructions for these two models, the Neptune 1 Gold and the Neptune 1 Bronze. This recall was issued after there were 2 reports of improper use resulting in tissue damage in surgical patients.
The first reported incident was of a Neptune 2 system that was used improperly as a passive chest drainage tube, with fatal results. The instructions had no warning to this effect.
The company is sending revised instructions and warning labels for staff education on the Neptune 1 Gold and the Neptune 1 Bronze users. They will also send this information for the Neptune 1 Silver and the Neptune 2 Ultra users who submit certificates of medical necessity.