Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying d...
FDA Device Recall #Z-0454-2013 — Class II — May 24, 2011
Recall Summary
| Recall Number | Z-0454-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 24, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Instruments Div. of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 5865 |
Product Description
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Reason for Recall
Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
Lot / Code Information
Part 0702-001-000 (120v) Lot 0733700353 through 1036100423
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| Z-1402-2022 | Class II | Triton Canister System (finished part numbers F... | Jan 22, 2020 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.