Zeppessis Reprocessing, LLC Recall: Zeppessis' reprocessed single-use manifolds (filters)
Zeppessis Reprocessing, LLC Recall: Zeppessis' reprocessed single-use manifolds (filters) is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zeppessis Reprocessing, LLC; Product: Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management
| Recalling firm | Zeppessis Reprocessing, LLC |
|---|---|
| Product | 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distributed in the states of California, Idaho, Oregon, and Washington. |
| Recall initiated | 20130816 |
| Recall number | Z-2212-2013 |
| Category | device |
| State | ID |
| Country | United States |
$29/mo
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