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F L U I D
W A S T E
M A N A G E M E N T
International customers warning labels to apply to their devices. The
warning states: "Do not apply high-flow suction or allow extended
exposure of suction to tissue associated with procedures that require
either no suction, low-vacuum or low-flow suction."
Months after the initial recall over the patient injuries, Stryker
extended the recall to inform customers that it never obtained 510(k)
clearance from the FDA for the Neptune 1 Silver, Neptune 2 Ultra and
a higher-powered Neptune 2 Ultra. Unlike the Neptune 1 Gold, these
devices hadn't received pre-market approval from the FDA.
Stryker plans to discontinue the Neptune 1 Silver and will withdraw
all support for the use of this device by March 1, 2014. After that date,
the FDA says you shouldn't use the Neptune 1 Silver. Stryker is working with the FDA to get clearance for the second generation of the
Ultra. Ms. Willoughby says she hopes that happens by next March.
Post-recall use of the Neptune
In the short term, the FDA is giving you the option to continue using
the Neptune until next March — but only if you have no alternative
systems for collecting and disposing of surgical fluid waste.
The FDA "is not currently asking Stryker to remove the Neptune 2
Ultra Waste Management System and the Neptune 1 Silver Waste
Management System from the U.S. market due to concerns that
removal would likely create immediate market shortages."
Considering that individual units range in price from $20,000 to
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