September 26, 2012
Over the summer, Stryker initiated a Class 1 recall of the Neptune Waste Management System.
Last week, Stryker notified customers that it is expanding the recall to include the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because those devices do not have 510(k) clearance, according to a press release from the US Food and Drug Administration (FDA).
Currently, the FDA does not consider the above devices to be legally marketed because their safety and effectiveness have not yet been determined. As such, the FDA advises that the devices not be used, and Stryker has ceased distribution of them until they are cleared by the FDA.
However, if customers do not have an alternative device and wish to continue using the Neptune devices, they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.
The Neptune Waste Management System was initially recalled because Stryker had 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, resulting in a fatality.
Customers who have questions about this recall should contact Stryker Instruments’ Recall Coordinator, Angela Ragainis, at 269.389.2316 or email@example.com (Mon-Fri, 8 am – 5 pm ET).
Click here to read the full press release from the FDA.