The FDA reports that, in the past 6 months, it's "become aware of additional death and injury reports related to" recalled Neptune fluid waste management devices. Incorrect application of the Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management systems' high-flow, high-suction vacuum, along with improper end-user training may be to blame for the recent patient death and injury reports, says an FDA alert.

The FDA has recommended that all healthcare providers discontinue use of the Neptune devices, instead using "alternative legally marketed devices" in their place. One requirement of continuing to use these devices under the Certificate of Medical Necessity is that all users must be adequately trained and have implemented the use of a pre-use checklist.

Stryker issued an updated recall notification on Feb. 20 for the Neptune 1 Silver and the Neptune 2 Ultra to remind customers of the steps needed to continue using the devices. Stryker has recalled all serial numbers of the Neptune 1 Gold Rover, Neptune 1 Silver Rover, Neptune 1 Bronze Rover and Neptune 2 Rover.

Stryker had halted the distribution and ordered a voluntary recall of the Neptune 1 Silver and Neptune 2 Ultra after an FDA advisory in the autumn that noted they'd never been cleared for U.S. sale. Unlike the Neptune 1 Gold, these devices hadn't received 510(k) pre-market approval. As a result, their safety and effectiveness were essentially untested, and the Neptune 2 Ultra was implicated in one report of serious injury and one report of death at the time.

Stephanie Wasek