Prompted by patient injuries and at least two deaths due to inappropriately applying high-flow, high-suction vacuums to passive chest drains, Stryker notified all users that the Neptune 1 Silver and Neptune 2 Ultra liquid waste management systems have been recalled.* FDA is recommending that healthcare providers transition to using alternative legally marketed devices in their place.
The Stryker Neptune Waste Management System product line is designed to eliminate the manual handling of liquid waste using a closed system to suction and collect liquids during surgical procedures and a proprietary docking station to automatically empty the liquid waste at the end of the procedure. The recall specifically names the two Neptune models that FDA claims are not cleared for marketing, but also addresses concerns about inadequate understanding among users regarding suction risks affecting all Neptune models.
ECRI Institute has been reporting on the Stryker Neptune recall since its inception, issuing exclusive Health Devices Alerts and special reports addressing the implications. Healthcare organizations need clear guidance on how to properly implement the recall of these widely used systems, which are costly to replace; individual units range in price from $20,000 to $30,000 each, and many hospitals have as many as one per operating room.
Hear the answers to the most popular questions asked at the webinar
ECRI Institute web conference Q&A
*This web conference is free for ECRI Institute Health Devices System™, Health Devices Gold™, and SELECTplus™ members. List price for archive recording and materials is $249.