Stryker stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.
Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died.
