FDA Device recall Z-2212-2013
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste m…
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste m… by Zeppessis Reprocessing, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2212-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-16 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zeppessis Reprocessing |
| Distribution | CA, ID, OR, WA |
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); 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
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.
Identifiers
| code_info | -Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (p…-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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2212-2013%22
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