Stryker Recalling Unapproved Neptune Systems

Stryker has halted the distribution and ordered a voluntary recall of its Neptune 1 Silver and Neptune 2 Ultra (120V and 230V) fluid waste management systems after an FDA advisory noted they'd never been cleared for U.S. sale.

Unlike the Neptune 1 Gold, these devices did not receive the agency's 510(k) pre-market approval. As a result, the FDA points out, their safety and effectiveness are essentially untested.

In the Sept. 25 recall notice, the FDA advises owners of Neptune 1 Silver and Neptune 2 Ultra systems not to use them, or, if they have no fluid waste disposal alternatives, to "weigh the risks and benefits associated with continued use of these devices" and submit a certificate of medical necessity to Stryker by Oct. 12.

The recall is an expansion of an earlier action, announced on June 5. The company recalled its instructions for use on the above-mentioned models as well as on the Neptune 1 Gold and Neptune 1 Bronze after receiving 2 reports linking improper use of the popular devices to tissue damage among surgical patients.

In 1 reported incident, a user post-operatively connected a Neptune 2 system to a passive chest drainage tube with fatal results, something the instructions did not warn against.

The company is distributing revised instructions for staff education and warning labels to Neptune 1 Gold and Neptune 1 Bronze users (as well as to Neptune 1 Silver and Neptune 2 Ultra users who submit certificates of medical necessity).

David Bernard