The Recall Desk
HighFDA (Devices)·Z-2524-2015·Announced 2015-09-09

Stryker Neptune 2 Waste Management System Docking Station Recall

Stryker is recalling Neptune 2 Waste Management System Docking Stations because a defective component may cause fluid leaks during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential dispensing of waste fluid or fresh water at the incorrect time, which poses a risk of harm in a medical setting, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the Neptune 2 Waste Management System Docking Station (120V and 230V), both new and refurbished units. The recall involves 524 units, of which 237 are non-conforming. These units were distributed worldwide, including in the United States and in Austria, Canada, Hong Kong, the Netherlands, Finland, and Spain.

The recall is due to a potential defect in the Fluid Coupling Sleeve, a component within the Docking Station. This component may be out of specification, which can cut or dislodge the PTFE seal. This failure can cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is the dispensing of waste fluid and/or fresh water from the Neptune 2 Rover at the incorrect time.

The affected units were manufactured between January 15, 2015, and June 3, 2015. Users should check their serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should contact Stryker for instructions on how to proceed with the recall.

The recalled product

Product
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suc

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)

  • Manufacturer Part Numbers: 0702-014-000 & 0702-014-000U
  • Manufactured between January 15
  • 2015 and June 3
  • 2015

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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