Device Recall Neptune Waste Management System 의 리콜

Recall

61747

Class 1

Z-2062-2012

2012-06-08

2012-08-15

Terminated

United States

2016-08-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109233

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. warning labels, which are pending distribution, are required on all neptune devices. further investigation found the neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) lacked fda 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. fda advises neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) not be used. however, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. if customers choose to continue use of the neptune silver, neptune 2 ultra (120v) or neptune 2 (230v), they must complete a certificate of medical necessity and return it to stryker by october 12, 2012.

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 up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions. On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices. At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept