Stryker Recalls Neptune Rover Waste Management System
October 18, 2012
On June 5, 2012, the medical technology company Stryker issued a Class 1 recall of its Neptune Waste Management System. According to Stryker’s website, the Neptune Waste Management system is a unit that allows healthcare professionals to manage solid and fluid waste within one product to minimize contact with potentially dangerous fluids.
The FDA has informed consumers that the recall was issued because Stryker received reports of serious injury and tissue damage associated with the company’s Neptune 2 product. In a press release dated September 25, 2012, the FDA cited an instance where one customer connected the Neptune 2 System to a patient’s passive chest drainage tube post operatively, resulting in their death.
In its press release about the Stryker recall, the FDA also cites the following product names:
- Neptune 1 Gold Rover
- Neptune 1 Gold Rover – International
- Neptune 1 Silver Rover
- Neptune Bronze
- Neptune 2 Rover UItra (120 V)
- Neptune 2 Rover Ultra (230 V)
According to the FDA, the initial labels (“Information for Use” or “IFU”) for all the aforementioned products did not provide a specific warning against connecting the Neptune Rover, a high vacuum/high flow device, to a passive drainage tube. As such, Stryker issued the recall and instructed customers to review a revised IFU, distribute the information to affected departments, educate any users of the warning, and send Stryker a confirmation once all of these actions have been completed.
The FDA said that customers in possession of Stryker’s Neptune 1 Gold, Neptune 1 Gold International or Neptune 1 Bronze are supposed to receive a follow-up mailing in October 2012 that contains warning labels and detailed instructions for the devices.
Stryker Recall Expanded
On September 18, 2012, Stryker then notified customers that the recall was being expanded to the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V). According to the FDA, these three devices do not have the required 510(k) clearance and are not legally marketed devices. Because these three devices do not currently have 510(k) clearance, the FDA said that it is unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System. Stryker has since halted the distribution of the Neptune Silver, Neptune 2 Ultra (120V) and the Neptune 2 Ultra (230V) until the FDA clears all three products.
The FDA said that it recommends that customers stop using the Neptune Silver, Neptune 2 Ultra (120V) and the Neptune 2 Ultra (230V) until the FDA has determined the efficacy and safety of these devices. If customers do not have an alternative device to use in the meantime, the FDA has told customers to “weigh the risks and benefits associated with continued use of these devices.”
Any customer that chooses to continue using the Neptune Silver, Neptune 2 Ultra (120V) and the Neptune 2 Ultra (230V) is required to complete and submit a Certificate of Medical Necessity to Stryker by October 12, 2012.
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