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Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Was...

FDA Device Recall #Z-2212-2013 — Class II — August 16, 2013

Recall Summary

Recall Number Z-2212-2013
Classification Class II — Moderate risk
Date Initiated August 16, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zeppessis Reprocessing, LLC
Location Garden City, ID
Product Type Devices
Quantity undetermined the distributed amounts

Product Description

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump.

Reason for Recall

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.

Distribution Pattern

Distributed in the states of California, Idaho, Oregon, and Washington.

Lot / Code Information

-Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000); -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000); -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).

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.

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