FDA (Devices) recall action 61747
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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 post operatively, resulting in a fatality. The current IFU did not specifically warn against connecting all Neptune Waste Management devices, which is a high vacuum/high flow device, to a passive drainage tube. June 12, 2012, customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Warnin…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.
Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.
Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.
Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.