The Recall Desk
ModerateFDA (Devices)·Z-2099-2015·Announced 2015-07-29

Stryker Neptune 2 Waste Management System Recalled for Diverter Valve Failures

Stryker is recalling the Neptune 2 Waste Management System due to installation failures of the diverter valve assembly during docking.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

Stryker Instruments Division of Stryker Corporation is recalling the Neptune 2 Waste Management System. The recall is initiated due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.

The affected products include the Neptune 2 Rover Ultra (120V and 230V), Neptune 2 Rover (230V), and the Diverter Valve Assembly. These devices are intended for use in operating rooms, pathology, surgical centers, and doctor's offices to collect and dispose of surgical fluid waste and evacuate surgical smoke. The Diverter Valve Assembly is used to direct water from the fresh water inlet to either the large or small canister via the pre-fill tank.

The recall covers 9,245 units with serial numbers ranging from 0803118093 through 1505400223. Distribution or repair dates range from November 1, 2011, to March 31, 2015. The products were distributed worldwide, including in the United States, Canada, Europe, Asia Pacific, and EEMEA. Users should contact Stryker Instruments for instructions on how to address the installation failures.

The recalled product

Product
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-0
Affected units
9,245

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Serial Numbers ranging from 0803118093 through 1505400223
  • Distribution or Repair dates: November 1
  • 2011 to March 31
  • 2015

Distribution

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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