Recall Z-2064-2012 ยท FYD Apparatus, Exhaust, Surgical
Stryker Instruments Div. of Stryker Corporation
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
| Date | Aug 15, 2012 (initiated Jun 8, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling False and Misleading |
| Action | On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions. Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow |
| Quantity | 10,394 domestic, 276 international |
| Distribution | Worldwide Distribution -- USA (nationwide) and country of: Canada. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM Stryker Instruments, Nov 29, 2001 |