Neptune 2 Rover Ultra Waste Management System.

FDA Recall #Z-0902-2014 — Class II — December 30, 2013

Recall #Z-0902-2014 Date: December 30, 2013 Classification: Class II Status: Terminated

Product Description

Neptune 2 Rover Ultra Waste Management System.

Reason for Recall

The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.

Recalling Firm

Stryker Instruments Div. of Stryker Corporation — Portage, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

Nationwide and Canada, Germany, Australia, New Zealand

Code Information

Manufacturer Part Number 0702-001-000 (120V) All serial numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated