On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.
The original problem it seems was that the instructions for use (IFU) did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the product, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality.
Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning.
The follow-up in the story is that on September 18, 2012, Stryker notified customers via letter that it is expanding the recall on 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 says it 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.
As such, the agency has advised that the devices not be used unless an alternative device cannot be sourced. UNder those circumstances customers have been advised to seek documentary certification from Stryker as a record of use.
The full FDA class 1 recall notice, including details of the products involved, can be found here.