Stryker Widens Recall of Surgical Waste Management Line
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Leana Shishakova
Stryker Corp. recalled its Neptune surgical waste management product line because it did not have proper regularity clearance as stated by U.S. health authorities.
There have been two reports of serous injury and a fatality resulting from the use of the product.
In a press release, Stryker, a maker of hospital beds and orthopedic implants, said the U.S. Food Drug Administration is unclear on whether these last-generation devices are safe or effective as their legally marketed predecessor, the Neptune 1.
The recall affects the following products: Neptune 1 Gold Rover; Neptune 1 Gold Rover- International; Neptune 1 Silver Rover; Neptune Bronze; Neptune 2 Rover Ultra (120 V); and Neptune 2 Rover Ultra (230 V).