Stryker Neptune Recall Issued for Waste Drainage Devices
A class 1 recall has been issued for Stryker’s Neptune Waste Management Systems following reports involving a number of serious injuries in connection with the devices, including at least one death.
An expanded Stryker Neptune Rover Waste Management System recall was issued on September 25, following an initial recall notice issued on June 5 for a limited number of the devices.
The FDA has determined that the action qualifies as a class 1 recall, which is the most serious type of medical device recall, after the agency notified the manufacturer that it has determined the products can not be established as safe or effective. The recall affects devices sold in the United States, Asia Pacific, Canada, Japan, Latin America and Europe.
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The initial recall impacted the Neptune 2 Rover, with Stryker warning clients against connecting the device to passive drainage tubes, after reports were received involving injury to users resulting in tissue damage and one fatality when the device was connected to a passive chest drainage tube post operative.
Stryker has now expanded the recall to include Neptune 1 Silver, Neptune 2 Ultra (120V), Neptune and 2 Ultra (320V) after the FDA notified the company that it was unauthorized for 510(k) clearance due to safety and effectiveness concerns. The FDA has advised consumers not to use these waste systems.
The series of Neptune Waste Management Systems are high vacuum/high flow devices used in operating rooms during surgeries to collect surgical waste. They are designed to collect the waste and dispose of the fluids without exposing healthcare workers.
Stryker also notified customers that it is recalling the instructions for use, as the initial label did not include the specific instructions included in the June 5 recall, which recommends against connecting the devices to passive drainage tubes. The lack of this specific warning has been linked to the one reported Neptune fatality.
Stryker notified its clients that they are required to submit a certificate of medical necessity and return it to the company by Oct. 12 if they choose to continue using the devices. The company also advised clients to weigh the risks and benefits of continued use carefully if there is no alternative device available.
Clients who continue use and submit the certificate of medical necessity will then receive followup safety details and instructions on proper use of the devices. The company has stopped distribution of the devices pending FDA approval.
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