Stryker issued an urgent medical device recall notice Tuesday noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance.
The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are being recalled because”Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube postoperatively,” killing the patient.
The company said that the U.S. Food and Drug Administration informed Stryker that the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) Waste Management systems do not have the requisite 510(k) clearance and customers should stop using these devices. The previous recall was designated a Class I.
As a result of the expanded recall, Stryker is no longer selling these products. Neptune 1 (Gold) Waste Management System is the predicate device for the models being recalled. Those customers who are using the Neptune 1 Gold,Neptune 1 Gold International and the Neptune 1 Bronze will receive follow-up letters containing the warning labels that now need to be applied with these devices.
But the announcement noted customers who are currently using the recalled models and do not have an alternative can continue to use them although they need to complete and return a Certificate of Medical Necessity form to Stryker by Oct. 12.
It wasn’t clear from the announcement why these later models of the Neptune 1 Waste Management System were being sold without a 510(k) clearance. A Stryker spokeswoman declined to comment.