KALAMAZOO — Stryker Corp. on Tuesday announced the expansion of the recall of its Neptune surgical waste management product line to include later versions.
Stryker initiated the initial recall in June after two reports of serious injury and one death among patients using the device.
Now, Stryker has notified customers that the U.S. Food and Drug Administration has advised Stryker that these devices don’t have regulatory clearance, and that the FDA can’t determine if they are as safe and effective as their predecessors.
The device collects surgical wastes in the operating room and disposes of them automatically, so health care workers don’t have to be exposed to the waste.
Stryker also said it was recalling the instructions for use of the products because they didn’t warn against connecting the Neptune Rover, a high-vacuum, high-flow device, to a passive drainage tube.
Stryker said the most recent recall affects the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) “because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices.”
At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by Oct. 12.
Customers who have questions about this recall should contact Stryker Instruments’ Recall Coordinator, Angela Ragainis, Monday through Friday from 8 a.m. to 5 p.m. Eastern time, at (269) 389-2316 or firstname.lastname@example.org.